A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication
Sponsor
Janssen-Ortho Inc., Canada (Industry)
Overall Status
Terminated
CT.gov ID
NCT00256997
Collaborator
(none)
167
44
2
39
3.8
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic medication) versus oral antipsychotics in schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants with a history of being poorly compliant with taking their medication.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This is a Phase 4, an open-label (all people know the identity of the intervention), multi-country and multi-centric (conducted in more than one center) study of risperidone long-acting formulation versus oral (having to do with the mouth) atypical antipsychotics in participants with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text revision ( DSM-IV TR) diagnosis of schizophrenia currently being treated with oral antipsychotic medication. The duration of this study will be 2 years. All the eligible participants will be randomly assigned to an oral atypical antipsychotic (risperidone, olanzapine, quetiapine, and where commercially available, aripiprazole and amisulpride) or to risperidone long-acting formulation. For risperidone long-acting formulation participants, study medication will be administered by intramuscular (into the muscle) injection every 2 weeks at doses of 25, 37.5 or 50 milligram (mg). Oral supplementation with the current oral atypical antipsychotic is required for the first 3 weeks following the initial injection and dose increase. Dose increase can be made as per product labeling. The primary measure of effectiveness is the reduction in the percentage of participants experiencing a clinical exacerbation after being in the study for 3 months. Participants' safety will be monitored throughout the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
167 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pragmatic Randomized Trial of Risperdal Consta Versus Oral Atypical Antipsychotics in Poorly Adherent Subjects With Schizophrenia in a Routine Care Setting
Study Start Date
:
Jan 1, 2006
Actual Primary Completion Date
:
Apr 1, 2009
Actual Study Completion Date
:
Apr 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Risperidone long-acting injection (LAI) Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months. |
Drug: Risperidone long-acting injection (LAI)
Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.
|
| Active Comparator: Oral atypical Antipsychotic Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion. |
Drug: Oral atypical Antipsychotic
Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization [Month 3 up to Month 24]
Clinical exacerbation is defined as hospitalization because of participant's schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.
Secondary Outcome Measures
- Percentage of Participants Who Experienced a Clinical Exacerbation [Baseline up to Month 24]
Clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.
- Time to First Clinical Exacerbation [Baseline up to Month 24]
Time to first clinical exacerbation was calculated over the entire trial duration wherein clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.
- Time in Symptomatic (Having Symptoms) Remission [Baseline up to Month 24]
Time in symptomatic (having symptoms) remission for participants on risperidone was compared with those on oral atypical medication and was calculated over the entire trial duration.
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 [Baseline and Month 24]
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.
- Number of Participants With Clinical Global Impression of Severity (CGI-S) [Baseline and End of Study (Month 24 or Early Withdrawal [EW])]
The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.
- Number of Participants With Clinical Global Impression of Change (CGI-C) [End of Study (Month 24 or Early Withdrawal [EW])]
The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.
- Number of Participants With Response to Resource Utilization Questionnaire (RUQ) [Baseline up to Month 24]
This questionnaire included questions asked to participants about any hospitalizations, visits to the emergency room or any other psychiatric treatment received in the previous month. Also the participants and/or primary health care contact or caregiver (or other modality to obtain accurate information) were telephoned on a monthly basis (1 month post Visit 2 through to end of study [Visit 6, Month 24]) by a member of the investigational staff and the resource utilization assessment was conducted over the phone.
- Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 [Baseline and Month 24]
AQoL is defined as an Australian-developed participant delivered quality of life (QoL) instrument consisting of 15-questions in 5 scales measuring illness, independence, social relationships, physical senses and psychological well-being. Each of the 5 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best] and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). The scores for independent living, social relationships, physical senses and psychological well-being are combined to obtain the QoL utility score which refers to the "value" of a health state to the respondent where the lower boundary is -0.04 (representing QoL state worse than death), 0.00 (death equivalent QoL state) and to 1.00 (best possible QoL state)".
- Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24 [Baseline and End of Study (Month 24 or Early Termination [ET])]
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria: - Diagnosis of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text revision (DSM-IV TR)- Have had at least 2 hospitalizations or 2 clinical worsening of symptoms, over the past 2 years because of deteriorating adherence - Is currently receiving treatment with an antipsychotic per local product label guidelines, and has a history in the last 5 years of a satisfactory response (minimum of 6 weeks) to oral antipsychotics (excluding clozapine) - On monotherapy antipsychotic treatment as per local product label guidelines, at Baseline -Female participants must be surgically sterile, or practicing an effective method of birth control before entry and throughout the study, and have a negative urine pregnancy test at screening before study entry Exclusion Criteria: - Participants with a primary DSM-IV TR Axis I diagnosis other than schizophrenia
- Female participants who are currently pregnant or breastfeeding or planning a pregnancy within 2 years of trial start - Have a serious, unstable and untreated medical illnesses, such as vascular or cardiovascular disease, history of liver or kidney disease, significant cardiac (having to do with the heart), pulmonary (having to do with the lungs), gastrointestinal, endocrine, neurological (pertaining to the nervous system) or metabolic disturbances - At significant risk of suicide or violence at study start - Evidence of substance dependence (except for nicotine and caffeine dependence) according to DSM-IV TR criteria diagnosed in the last month prior to entry
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dandenong | Australia | |||
| 2 | Frankston | Australia | |||
| 3 | Mt Claremont | Australia | |||
| 4 | Newcastle | Australia | |||
| 5 | Southport | Australia | |||
| 6 | Calgary | Alberta | Canada | ||
| 7 | Bathurst | New Brunswick | Canada | ||
| 8 | Kentville | Nova Scotia | Canada | ||
| 9 | Sydney | Nova Scotia | Canada | ||
| 10 | Kingston | Ontario | Canada | ||
| 11 | Mississauga | Ontario | Canada | ||
| 12 | Sudbury | Ontario | Canada | ||
| 13 | Beauport | Quebec | Canada | ||
| 14 | Montreal | Quebec | Canada | ||
| 15 | Saint-Georges | Quebec | Canada | ||
| 16 | Battleford | Saskatchewan | Canada | ||
| 17 | Prince Albert | Saskatchewan | Canada | ||
| 18 | Montreal | Canada | |||
| 19 | Quebec | Canada | |||
| 20 | Saint John | Canada | |||
| 21 | Co.Mayo | Ireland | |||
| 22 | Dublin | Ireland | |||
| 23 | Mullingar | Ireland | |||
| 24 | Birmingham | United Kingdom | |||
| 25 | Boston | United Kingdom | |||
| 26 | Bristol | United Kingdom | |||
| 27 | Burnley | United Kingdom | |||
| 28 | Darwen | United Kingdom | |||
| 29 | Devon | United Kingdom | |||
| 30 | Grantham | United Kingdom | |||
| 31 | Leicester | United Kingdom | |||
| 32 | Lincoln | United Kingdom | |||
| 33 | London | United Kingdom | |||
| 34 | Morpeth | United Kingdom | |||
| 35 | Newcastle Upon Tyne | United Kingdom | |||
| 36 | Northampton | United Kingdom | |||
| 37 | Nottingham | United Kingdom | |||
| 38 | Preston | United Kingdom | |||
| 39 | Stamford | United Kingdom | |||
| 40 | Stockton-Upon-Tees | United Kingdom | |||
| 41 | Swansea | United Kingdom | |||
| 42 | Teignmouth | United Kingdom | |||
| 43 | Wallsend | United Kingdom | |||
| 44 | Weston Super Mare | United Kingdom |
Sponsors and Collaborators
- Janssen-Ortho Inc., Canada
Investigators
- Study Director: Janssen Inc. Clinical Trial, Janssen Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:
NCT00256997
Other Study ID Numbers:
- CR006016
- RISSCH4055
First Posted:
Nov 22, 2005
Last Update Posted:
Dec 5, 2013
Last Verified:
Nov 1, 2013
Keywords provided by Janssen-Ortho Inc., Canada
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Risperidone Long-Acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Period Title: Overall Study | ||
| STARTED | 81 | 86 |
| Treated | 79 | 86 |
| COMPLETED | 33 | 31 |
| NOT COMPLETED | 48 | 55 |
Baseline Characteristics
| Arm/Group Title | Risperidone Long-Acting Injection (LAI) | Oral Atypical Antipsychotic | Total |
|---|---|---|---|
| Arm/Group Description | Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. | Total of all reporting groups |
| Overall Participants | 79 | 86 | 165 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
37.4
(12.46)
|
38.9
(10.9)
|
38.2
(11.67)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
23
29.1%
|
23
26.7%
|
46
27.9%
|
| Male |
56
70.9%
|
63
73.3%
|
119
72.1%
|
Outcome Measures
| Title | Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization |
|---|---|
| Description | Clinical exacerbation is defined as hospitalization because of participant's schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control. |
| Time Frame | Month 3 up to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. |
| Arm/Group Title | Risperidone Long-Acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Measure Participants | 79 | 86 |
| Number [Percentage of participants] |
48.1
60.9%
|
43.0
50%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risperidone Long-Acting Injection (LAI), Oral Atypical Antipsychotic |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5498 |
| Comments | P-value was calculated by Cox proportional hazard model stratified for positive and negative symptom scale. | |
| Method | Cox proportional hazard model | |
| Comments | ||
| Title | Percentage of Participants Who Experienced a Clinical Exacerbation |
|---|---|
| Description | Clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control. |
| Time Frame | Baseline up to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. |
| Arm/Group Title | Risperidone Long-acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Measure Participants | 79 | 86 |
| Number [Percentage of participants] |
54.4
68.9%
|
54.7
63.6%
|
| Title | Time to First Clinical Exacerbation |
|---|---|
| Description | Time to first clinical exacerbation was calculated over the entire trial duration wherein clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control. |
| Time Frame | Baseline up to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. |
| Arm/Group Title | Risperidone Long-acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Measure Participants | 78 | 85 |
| Mean (Standard Error) [Months] |
10.4
(0.80)
|
11.2
(0.93)
|
| Title | Time in Symptomatic (Having Symptoms) Remission |
|---|---|
| Description | Time in symptomatic (having symptoms) remission for participants on risperidone was compared with those on oral atypical medication and was calculated over the entire trial duration. |
| Time Frame | Baseline up to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data for this outcome was not computed as it was not defined in terms of the formula for calculation and thus was not included in analysis plan. |
| Arm/Group Title | Risperidone Long-acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Measure Participants | 0 | 0 |
| Title | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 |
|---|---|
| Description | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. |
| Arm/Group Title | Risperidone Long-acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Measure Participants | 79 | 85 |
| Baseline (n=79, 85) |
77.6
(17.24)
|
76.5
(17.83)
|
| Change at Month 24: Total score (n=67, 67) |
-9.6
(19.80)
|
-12.4
(21.83)
|
| Title | Number of Participants With Clinical Global Impression of Severity (CGI-S) |
|---|---|
| Description | The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening. |
| Time Frame | Baseline and End of Study (Month 24 or Early Withdrawal [EW]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. |
| Arm/Group Title | Risperidone Long-acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Measure Participants | 79 | 85 |
| Baseline: Mild or better (n=79, 85) |
18
22.8%
|
26
30.2%
|
| Baseline: Moderate, marked and severe (n=79, 85) |
61
77.2%
|
59
68.6%
|
| Month 24/EW: Mild or better (n=67, 68) |
36
45.6%
|
39
45.3%
|
| Month 24/EW:Moderate,marked and severe (n=67, 68) |
31
39.2%
|
29
33.7%
|
| Title | Number of Participants With Clinical Global Impression of Change (CGI-C) |
|---|---|
| Description | The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening. |
| Time Frame | End of Study (Month 24 or Early Withdrawal [EW]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. |
| Arm/Group Title | Risperidone Long-acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Measure Participants | 67 | 68 |
| Month 24/EW:At least minimally improved(n= 67,68) |
48
60.8%
|
38
44.2%
|
| Month 24/EW: No change or worse (n=67,68) |
19
24.1%
|
30
34.9%
|
| Title | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) |
|---|---|
| Description | This questionnaire included questions asked to participants about any hospitalizations, visits to the emergency room or any other psychiatric treatment received in the previous month. Also the participants and/or primary health care contact or caregiver (or other modality to obtain accurate information) were telephoned on a monthly basis (1 month post Visit 2 through to end of study [Visit 6, Month 24]) by a member of the investigational staff and the resource utilization assessment was conducted over the phone. |
| Time Frame | Baseline up to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. |
| Arm/Group Title | Risperidone Long-acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Measure Participants | 79 | 86 |
| Emergency room visits (total reports) |
32
40.5%
|
29
33.7%
|
| Hospital admissions (total reports) |
42
53.2%
|
32
37.2%
|
| Family doctor visits (total reports) |
59
74.7%
|
58
67.4%
|
| Psychologist doctor visit (total reports) |
14
17.7%
|
13
15.1%
|
| Social worker (total reports) |
43
54.4%
|
44
51.2%
|
| Occupational therapist (total reports) |
28
35.4%
|
30
34.9%
|
| Phychiatric day care (total reports) |
19
24.1%
|
13
15.1%
|
| Phychiatrist (total reports) |
74
93.7%
|
78
90.7%
|
| Visit by a home care nurse (total reports) |
15
19%
|
8
9.3%
|
| Psychiatric nurse (total reports) |
62
78.5%
|
58
67.4%
|
| Suicide/crisis services (total reports) |
13
16.5%
|
13
15.1%
|
| Outpatient clinic (total reports) |
31
39.2%
|
36
41.9%
|
| Title | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 |
|---|---|
| Description | AQoL is defined as an Australian-developed participant delivered quality of life (QoL) instrument consisting of 15-questions in 5 scales measuring illness, independence, social relationships, physical senses and psychological well-being. Each of the 5 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best] and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). The scores for independent living, social relationships, physical senses and psychological well-being are combined to obtain the QoL utility score which refers to the "value" of a health state to the respondent where the lower boundary is -0.04 (representing QoL state worse than death), 0.00 (death equivalent QoL state) and to 1.00 (best possible QoL state)". |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. |
| Arm/Group Title | Risperidone Long-acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Measure Participants | 79 | 84 |
| Baseline: Illness score (n=79,84) |
0.396
(0.2496)
|
0.359
(0.2549)
|
| Change at Month 24: Illness score (n=64,67) |
0.091
(0.3086)
|
0.035
(0.3101)
|
| Baseline: Daily activity score(n=79,83) |
0.811
(0.2312)
|
0.872
(0.2156)
|
| Change at Month 24: Daily activity score(n=64,67) |
0.051
(0.2370)
|
-0.038
(0.2283)
|
| Baseline: Social score (n=79,83) |
0.608
(0.2926)
|
0.613
(0.3117)
|
| Change at Month 24: Social score (n=64,66) |
0.060
(0.3143)
|
0.025
(0.3474)
|
| Baseline: Physical score (n=79,83) |
0.872
(0.1437)
|
0.916
(0.1022)
|
| Change at Month 24: Physical score (n=64,67) |
0.065
(0.1581)
|
0.020
(0.0919)
|
| Baseline: Psychological score (n=79,83) |
0.863
(0.1469)
|
0.863
(0.1595)
|
| Change at Month 24: Psychological score (64,67) |
0.015
(0.1677)
|
0.023
(0.01527)
|
| Title | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24 |
|---|---|
| Description | The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). |
| Time Frame | Baseline and End of Study (Month 24 or Early Termination [ET]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. |
| Arm/Group Title | Risperidone Long-acting Injection (LAI) | Oral Atypical Antipsychotic |
|---|---|---|
| Arm/Group Description | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. |
| Measure Participants | 79 | 84 |
| Baseline: (n=79, 84) |
54.2
(13.32)
|
55.0
(13.49)
|
| Change at Month 24/ET: (n=67,68) |
5.2
(17.76)
|
8.4
(15.72)
|
Adverse Events
| Time Frame | Baseline up to Month 24 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All participants of the ITT population were included in the safety analysis set. This set thus consisted of 167 participants, 81 randomly assigned to risperidone long-acting injection (LAI), 86 participants randomly assigned to oral antipsychotic treatment. | |||
| Arm/Group Title | Risperidone Long-Acting Injection (LAI) | Oral Atypical Antipsychotic | ||
| Arm/Group Description | Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. | ||
All Cause Mortality |
||||
| Risperidone Long-Acting Injection (LAI) | Oral Atypical Antipsychotic | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Risperidone Long-Acting Injection (LAI) | Oral Atypical Antipsychotic | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/81 (17.3%) | 6/86 (7%) | ||
| Cardiac disorders | ||||
| Acute coronary syndrome | 1/81 (1.2%) | 0/86 (0%) | ||
| Angina pectoris | 2/81 (2.5%) | 0/86 (0%) | ||
| Myocardial infarction | 1/81 (1.2%) | 0/86 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/81 (1.2%) | 0/86 (0%) | ||
| Dyspepsia | 1/81 (1.2%) | 0/86 (0%) | ||
| General disorders | ||||
| Chest pain | 2/81 (2.5%) | 0/86 (0%) | ||
| Irritability | 1/81 (1.2%) | 0/86 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholelithiasis | 1/81 (1.2%) | 0/86 (0%) | ||
| Infections and infestations | ||||
| Diverticulitis | 0/81 (0%) | 1/86 (1.2%) | ||
| Respiratory tract infection | 1/81 (1.2%) | 0/86 (0%) | ||
| Urosepsis | 1/81 (1.2%) | 0/86 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Alcohol poisoning | 1/81 (1.2%) | 0/86 (0%) | ||
| Foot fracture | 1/81 (1.2%) | 0/86 (0%) | ||
| Fracture | 0/81 (0%) | 1/86 (1.2%) | ||
| Laceration | 0/81 (0%) | 1/86 (1.2%) | ||
| Overdose | 1/81 (1.2%) | 0/86 (0%) | ||
| Investigations | ||||
| Weight decreased | 1/81 (1.2%) | 0/86 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 1/81 (1.2%) | 0/86 (0%) | ||
| Dehydration | 2/81 (2.5%) | 0/86 (0%) | ||
| Electrolyte imbalance | 1/81 (1.2%) | 0/86 (0%) | ||
| Malnutrition | 1/81 (1.2%) | 0/86 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Pain in extremity | 1/81 (1.2%) | 0/86 (0%) | ||
| Rhabdomyolysis | 1/81 (1.2%) | 0/86 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Non-hodgkin's lymphoma | 1/81 (1.2%) | 0/86 (0%) | ||
| Nervous system disorders | ||||
| Syncope | 1/81 (1.2%) | 0/86 (0%) | ||
| Psychiatric disorders | ||||
| Affect lability | 1/81 (1.2%) | 0/86 (0%) | ||
| Agitation | 1/81 (1.2%) | 0/86 (0%) | ||
| Confusional state | 1/81 (1.2%) | 0/86 (0%) | ||
| Delirium | 1/81 (1.2%) | 0/86 (0%) | ||
| Delusion of grandeur | 0/81 (0%) | 1/86 (1.2%) | ||
| Hallucination | 1/81 (1.2%) | 0/86 (0%) | ||
| Hallucination, auditory | 1/81 (1.2%) | 0/86 (0%) | ||
| Hostility | 1/81 (1.2%) | 0/86 (0%) | ||
| Psychotic disorder | 0/81 (0%) | 1/86 (1.2%) | ||
| Suicidal ideation | 1/81 (1.2%) | 0/86 (0%) | ||
| Renal and urinary disorders | ||||
| Renal failure acute | 1/81 (1.2%) | 0/86 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/81 (1.2%) | 0/86 (0%) | ||
| Respiratory distress | 1/81 (1.2%) | 0/86 (0%) | ||
| Surgical and medical procedures | ||||
| Surgery | 0/81 (0%) | 1/86 (1.2%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Risperidone Long-Acting Injection (LAI) | Oral Atypical Antipsychotic | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 70/81 (86.4%) | 69/86 (80.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Cardiac disorders | ||||
| Arrhythmia | 0/81 (0%) | 1/86 (1.2%) | ||
| Bradycardia | 1/81 (1.2%) | 0/86 (0%) | ||
| Extrasystoles | 1/81 (1.2%) | 0/86 (0%) | ||
| Palpitations | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Tachycardia | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Ear and labyrinth disorders | ||||
| Ear pain | 1/81 (1.2%) | 0/86 (0%) | ||
| Vertigo | 0/81 (0%) | 1/86 (1.2%) | ||
| Endocrine disorders | ||||
| Hyperprolactinaemia | 1/81 (1.2%) | 0/86 (0%) | ||
| Eye disorders | ||||
| Asthenopia | 1/81 (1.2%) | 0/86 (0%) | ||
| Blepharopachynsis | 0/81 (0%) | 1/86 (1.2%) | ||
| Conjunctivitis | 1/81 (1.2%) | 0/86 (0%) | ||
| Diabetic retinopathy | 0/81 (0%) | 1/86 (1.2%) | ||
| Eye irritation | 2/81 (2.5%) | 0/86 (0%) | ||
| Eye pain | 1/81 (1.2%) | 0/86 (0%) | ||
| Eye pruritus | 1/81 (1.2%) | 0/86 (0%) | ||
| Vision blurred | 1/81 (1.2%) | 0/86 (0%) | ||
| Visual impairment | 1/81 (1.2%) | 0/86 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 0/81 (0%) | 3/86 (3.5%) | ||
| Abdominal distension | 0/81 (0%) | 1/86 (1.2%) | ||
| Abdominal pain | 3/81 (3.7%) | 0/86 (0%) | ||
| Abdominal pain upper | 0/81 (0%) | 1/86 (1.2%) | ||
| Barrett's oesophagus | 1/81 (1.2%) | 0/86 (0%) | ||
| Cheilitis | 0/81 (0%) | 1/86 (1.2%) | ||
| Constipation | 3/81 (3.7%) | 4/86 (4.7%) | ||
| Diarrhoea | 5/81 (6.2%) | 4/86 (4.7%) | ||
| Dry mouth | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Dyspepsia | 4/81 (4.9%) | 2/86 (2.3%) | ||
| Flatulence | 1/81 (1.2%) | 0/86 (0%) | ||
| Food poisoning | 1/81 (1.2%) | 0/86 (0%) | ||
| Gastrooesophageal reflux disease | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Haemorrhoids | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Hypoaesthesia oral | 1/81 (1.2%) | 0/86 (0%) | ||
| Inguinal hernia | 0/81 (0%) | 1/86 (1.2%) | ||
| Nausea | 8/81 (9.9%) | 5/86 (5.8%) | ||
| Rectal haemorrhage | 0/81 (0%) | 1/86 (1.2%) | ||
| Salivary hypersecretion | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Swollen tongue | 1/81 (1.2%) | 0/86 (0%) | ||
| Tongue disorder | 1/81 (1.2%) | 0/86 (0%) | ||
| Toothache | 3/81 (3.7%) | 0/86 (0%) | ||
| Vomiting | 7/81 (8.6%) | 5/86 (5.8%) | ||
| General disorders | ||||
| Asthenia | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Chest pain | 3/81 (3.7%) | 4/86 (4.7%) | ||
| Crepitations | 0/81 (0%) | 1/86 (1.2%) | ||
| Cyst | 0/81 (0%) | 1/86 (1.2%) | ||
| Facial pain | 1/81 (1.2%) | 0/86 (0%) | ||
| Fatigue | 5/81 (6.2%) | 5/86 (5.8%) | ||
| Feeling abnormal | 0/81 (0%) | 1/86 (1.2%) | ||
| Feeling cold | 1/81 (1.2%) | 0/86 (0%) | ||
| Gait disturbance | 1/81 (1.2%) | 0/86 (0%) | ||
| Injection site pain | 2/81 (2.5%) | 2/86 (2.3%) | ||
| Malaise | 0/81 (0%) | 1/86 (1.2%) | ||
| Oedema | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Oedema peripheral | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Pain | 2/81 (2.5%) | 3/86 (3.5%) | ||
| Pyrexia | 0/81 (0%) | 1/86 (1.2%) | ||
| Sluggishness | 0/81 (0%) | 1/86 (1.2%) | ||
| Swelling | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 2/81 (2.5%) | 2/86 (2.3%) | ||
| Seasonal allergy | 0/81 (0%) | 1/86 (1.2%) | ||
| Infections and infestations | ||||
| Abscess | 1/81 (1.2%) | 0/86 (0%) | ||
| Acarodermatitis | 0/81 (0%) | 1/86 (1.2%) | ||
| Bronchitis | 1/81 (1.2%) | 0/86 (0%) | ||
| Candidiasis | 1/81 (1.2%) | 2/86 (2.3%) | ||
| Cellulitis | 1/81 (1.2%) | 0/86 (0%) | ||
| Ear infection | 2/81 (2.5%) | 0/86 (0%) | ||
| External ear cellulitis | 1/81 (1.2%) | 0/86 (0%) | ||
| Eye infection | 0/81 (0%) | 1/86 (1.2%) | ||
| Fungal infection | 0/81 (0%) | 2/86 (2.3%) | ||
| Furuncle | 1/81 (1.2%) | 0/86 (0%) | ||
| Gastroenteritis | 2/81 (2.5%) | 0/86 (0%) | ||
| Helminthic infection | 1/81 (1.2%) | 0/86 (0%) | ||
| Herpes zoster | 0/81 (0%) | 1/86 (1.2%) | ||
| Infection | 1/81 (1.2%) | 3/86 (3.5%) | ||
| Influenza | 3/81 (3.7%) | 4/86 (4.7%) | ||
| Laryngitis | 1/81 (1.2%) | 0/86 (0%) | ||
| Lower respiratory tract infection | 3/81 (3.7%) | 0/86 (0%) | ||
| Nasopharyngitis | 7/81 (8.6%) | 7/86 (8.1%) | ||
| Oral candidiasis | 0/81 (0%) | 1/86 (1.2%) | ||
| Oral infection | 0/81 (0%) | 1/86 (1.2%) | ||
| Otitis externa | 1/81 (1.2%) | 0/86 (0%) | ||
| Pneumonia | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Respiratory tract infection | 0/81 (0%) | 1/86 (1.2%) | ||
| Rhinitis | 1/81 (1.2%) | 0/86 (0%) | ||
| Sinusitis | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Subcutaneous abscess | 1/81 (1.2%) | 0/86 (0%) | ||
| Tooth abscess | 3/81 (3.7%) | 2/86 (2.3%) | ||
| Tooth infection | 2/81 (2.5%) | 0/86 (0%) | ||
| Upper respiratory tract infection | 2/81 (2.5%) | 1/86 (1.2%) | ||
| Urinary tract infection | 1/81 (1.2%) | 3/86 (3.5%) | ||
| Viral infection | 1/81 (1.2%) | 0/86 (0%) | ||
| Wound infection | 1/81 (1.2%) | 0/86 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Excoriation | 0/81 (0%) | 1/86 (1.2%) | ||
| Intentional overdose | 1/81 (1.2%) | 0/86 (0%) | ||
| Joint injury | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Joint sprain | 0/81 (0%) | 3/86 (3.5%) | ||
| Ligament sprain | 1/81 (1.2%) | 0/86 (0%) | ||
| Limb injury | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Medication error | 0/81 (0%) | 1/86 (1.2%) | ||
| Muscle strain | 1/81 (1.2%) | 0/86 (0%) | ||
| Overdose | 0/81 (0%) | 2/86 (2.3%) | ||
| Periorbital haematoma | 1/81 (1.2%) | 0/86 (0%) | ||
| Whiplash injury | 0/81 (0%) | 1/86 (1.2%) | ||
| Wound | 1/81 (1.2%) | 0/86 (0%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 3/81 (3.7%) | 0/86 (0%) | ||
| Aspartate aminotransferase increased | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Blood alcohol increased | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Blood cholesterol | 1/81 (1.2%) | 0/86 (0%) | ||
| Blood cholesterol increased | 2/81 (2.5%) | 3/86 (3.5%) | ||
| Blood creatine phosphokinase increased | 1/81 (1.2%) | 0/86 (0%) | ||
| Blood creatinine increased | 0/81 (0%) | 1/86 (1.2%) | ||
| Blood glucose increased | 2/81 (2.5%) | 5/86 (5.8%) | ||
| Blood ketone body | 0/81 (0%) | 1/86 (1.2%) | ||
| Blood pressure diastolic increased | 1/81 (1.2%) | 0/86 (0%) | ||
| Blood pressure increased | 1/81 (1.2%) | 3/86 (3.5%) | ||
| Blood prolactin increased | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Blood triglycerides | 0/81 (0%) | 1/86 (1.2%) | ||
| Blood triglycerides increased | 2/81 (2.5%) | 3/86 (3.5%) | ||
| Blood urea increased | 0/81 (0%) | 1/86 (1.2%) | ||
| Blood urine present | 0/81 (0%) | 2/86 (2.3%) | ||
| Electrocardiogram qt prolonged | 0/81 (0%) | 1/86 (1.2%) | ||
| Gamma-glutamyltransferase increased | 1/81 (1.2%) | 3/86 (3.5%) | ||
| Glucose urine present | 1/81 (1.2%) | 0/86 (0%) | ||
| Glycosylated haemoglobin increased | 1/81 (1.2%) | 2/86 (2.3%) | ||
| Heart rate increased | 0/81 (0%) | 1/86 (1.2%) | ||
| High density lipoprotein decreased | 1/81 (1.2%) | 0/86 (0%) | ||
| Laboratory test abnormal | 2/81 (2.5%) | 3/86 (3.5%) | ||
| Liver function test abnormal | 0/81 (0%) | 1/86 (1.2%) | ||
| Low density lipoprotein increased | 2/81 (2.5%) | 2/86 (2.3%) | ||
| Murphy's sign positive | 0/81 (0%) | 1/86 (1.2%) | ||
| Neutrophil count decreased | 1/81 (1.2%) | 0/86 (0%) | ||
| Protein urine | 1/81 (1.2%) | 0/86 (0%) | ||
| Semen volume decreased | 0/81 (0%) | 1/86 (1.2%) | ||
| Weight decreased | 2/81 (2.5%) | 2/86 (2.3%) | ||
| Weight increased | 13/81 (16%) | 10/86 (11.6%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 1/81 (1.2%) | 2/86 (2.3%) | ||
| Central obesity | 1/81 (1.2%) | 0/86 (0%) | ||
| Decreased appetite | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Diabetes mellitus | 0/81 (0%) | 1/86 (1.2%) | ||
| Dyslipidaemia | 2/81 (2.5%) | 0/86 (0%) | ||
| Glucose tolerance impaired | 0/81 (0%) | 1/86 (1.2%) | ||
| Hypercholesterolaemia | 1/81 (1.2%) | 0/86 (0%) | ||
| Hyperkalaemia | 0/81 (0%) | 1/86 (1.2%) | ||
| Hyponatraemia | 0/81 (0%) | 1/86 (1.2%) | ||
| Increased appetite | 0/81 (0%) | 1/86 (1.2%) | ||
| Metabolic syndrome | 0/81 (0%) | 1/86 (1.2%) | ||
| Type 2 diabetes mellitus | 0/81 (0%) | 1/86 (1.2%) | ||
| Vitamin B12 deficiency | 0/81 (0%) | 1/86 (1.2%) | ||
| Vitamin K deficiency | 1/81 (1.2%) | 0/86 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 6/81 (7.4%) | 5/86 (5.8%) | ||
| Back pain | 4/81 (4.9%) | 7/86 (8.1%) | ||
| Flank pain | 0/81 (0%) | 1/86 (1.2%) | ||
| Joint range of motion decreased | 0/81 (0%) | 1/86 (1.2%) | ||
| Joint stiffness | 1/81 (1.2%) | 2/86 (2.3%) | ||
| Joint swelling | 1/81 (1.2%) | 2/86 (2.3%) | ||
| Limb discomfort | 0/81 (0%) | 1/86 (1.2%) | ||
| Muscle rigidity | 2/81 (2.5%) | 0/86 (0%) | ||
| Muscle spasms | 4/81 (4.9%) | 2/86 (2.3%) | ||
| Muscle twitching | 0/81 (0%) | 2/86 (2.3%) | ||
| Musculoskeletal discomfort | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Musculoskeletal pain | 5/81 (6.2%) | 1/86 (1.2%) | ||
| Musculoskeletal stiffness | 3/81 (3.7%) | 2/86 (2.3%) | ||
| Myalgia | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Nuchal rigidity | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Pain in extremity | 6/81 (7.4%) | 6/86 (7%) | ||
| Sensation of heaviness | 0/81 (0%) | 1/86 (1.2%) | ||
| Synovial cyst | 1/81 (1.2%) | 0/86 (0%) | ||
| Trismus | 1/81 (1.2%) | 0/86 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Neoplasm malignant | 1/81 (1.2%) | 0/86 (0%) | ||
| Uterine leiomyoma | 0/81 (0%) | 1/86 (1.2%) | ||
| Nervous system disorders | ||||
| Akathisia | 5/81 (6.2%) | 4/86 (4.7%) | ||
| Bradykinesia | 1/81 (1.2%) | 0/86 (0%) | ||
| Coordination abnormal | 1/81 (1.2%) | 0/86 (0%) | ||
| Dementia | 1/81 (1.2%) | 0/86 (0%) | ||
| Disturbance in attention | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Dizziness | 11/81 (13.6%) | 10/86 (11.6%) | ||
| Dreamy state | 1/81 (1.2%) | 0/86 (0%) | ||
| Dyskinesia | 2/81 (2.5%) | 0/86 (0%) | ||
| Dystonia | 1/81 (1.2%) | 0/86 (0%) | ||
| Extrapyramidal disorder | 1/81 (1.2%) | 3/86 (3.5%) | ||
| Headache | 21/81 (25.9%) | 7/86 (8.1%) | ||
| Hypersomnia | 0/81 (0%) | 1/86 (1.2%) | ||
| Hypoaesthesia | 1/81 (1.2%) | 0/86 (0%) | ||
| Hypokinesia | 1/81 (1.2%) | 0/86 (0%) | ||
| Lethargy | 2/81 (2.5%) | 3/86 (3.5%) | ||
| Loss of consciousness | 1/81 (1.2%) | 0/86 (0%) | ||
| Memory impairment | 1/81 (1.2%) | 0/86 (0%) | ||
| Mental impairment | 1/81 (1.2%) | 0/86 (0%) | ||
| Optic neuritis | 0/81 (0%) | 1/86 (1.2%) | ||
| Paraesthesia | 0/81 (0%) | 1/86 (1.2%) | ||
| Poor quality sleep | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Restless legs syndrome | 4/81 (4.9%) | 0/86 (0%) | ||
| Sciatica | 0/81 (0%) | 1/86 (1.2%) | ||
| Sedation | 1/81 (1.2%) | 6/86 (7%) | ||
| Somnolence | 5/81 (6.2%) | 5/86 (5.8%) | ||
| Speech disorder | 1/81 (1.2%) | 0/86 (0%) | ||
| Syncope | 0/81 (0%) | 1/86 (1.2%) | ||
| Tardive dyskinesia | 0/81 (0%) | 1/86 (1.2%) | ||
| Tremor | 5/81 (6.2%) | 3/86 (3.5%) | ||
| Psychiatric disorders | ||||
| Abnormal behaviour | 0/81 (0%) | 1/86 (1.2%) | ||
| Aggression | 2/81 (2.5%) | 1/86 (1.2%) | ||
| Agitation | 12/81 (14.8%) | 11/86 (12.8%) | ||
| Anger | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Anxiety | 18/81 (22.2%) | 14/86 (16.3%) | ||
| Apathy | 1/81 (1.2%) | 0/86 (0%) | ||
| Communication disorder | 1/81 (1.2%) | 0/86 (0%) | ||
| Confusional state | 2/81 (2.5%) | 0/86 (0%) | ||
| Delusion | 2/81 (2.5%) | 1/86 (1.2%) | ||
| Depressed mood | 4/81 (4.9%) | 3/86 (3.5%) | ||
| Depression | 10/81 (12.3%) | 4/86 (4.7%) | ||
| Depressive symptom | 2/81 (2.5%) | 3/86 (3.5%) | ||
| Drug abuse | 1/81 (1.2%) | 0/86 (0%) | ||
| Elevated mood | 1/81 (1.2%) | 0/86 (0%) | ||
| Emotional distress | 1/81 (1.2%) | 2/86 (2.3%) | ||
| Hallucination, auditory | 4/81 (4.9%) | 1/86 (1.2%) | ||
| Hallucination, visual | 2/81 (2.5%) | 0/86 (0%) | ||
| Ideas of reference | 0/81 (0%) | 1/86 (1.2%) | ||
| Inappropriate affect | 1/81 (1.2%) | 2/86 (2.3%) | ||
| Insomnia | 21/81 (25.9%) | 12/86 (14%) | ||
| Libido decreased | 0/81 (0%) | 1/86 (1.2%) | ||
| Mood swings | 1/81 (1.2%) | 0/86 (0%) | ||
| Nightmare | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Obsessive-compulsive disorder | 1/81 (1.2%) | 0/86 (0%) | ||
| Orgasm abnormal | 0/81 (0%) | 1/86 (1.2%) | ||
| Orgasmic sensation decreased | 0/81 (0%) | 1/86 (1.2%) | ||
| Panic attack | 1/81 (1.2%) | 0/86 (0%) | ||
| Paranoia | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Persecutory delusion | 1/81 (1.2%) | 0/86 (0%) | ||
| Pressure of speech | 0/81 (0%) | 1/86 (1.2%) | ||
| Psychotic disorder | 4/81 (4.9%) | 5/86 (5.8%) | ||
| Restlessness | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Schizophrenia | 4/81 (4.9%) | 3/86 (3.5%) | ||
| Sleep disorder | 0/81 (0%) | 2/86 (2.3%) | ||
| Social avoidant behaviour | 1/81 (1.2%) | 0/86 (0%) | ||
| Suicidal ideation | 3/81 (3.7%) | 2/86 (2.3%) | ||
| Suicide attempt | 0/81 (0%) | 1/86 (1.2%) | ||
| Tachyphrenia | 1/81 (1.2%) | 0/86 (0%) | ||
| Tic | 0/81 (0%) | 1/86 (1.2%) | ||
| Renal and urinary disorders | ||||
| Bladder irritation | 0/81 (0%) | 1/86 (1.2%) | ||
| Haematuria | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Microalbuminuria | 0/81 (0%) | 1/86 (1.2%) | ||
| Urinary incontinence | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Urinary retention | 0/81 (0%) | 1/86 (1.2%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 0/81 (0%) | 1/86 (1.2%) | ||
| Breast enlargement | 0/81 (0%) | 1/86 (1.2%) | ||
| Dysmenorrhoea | 2/81 (2.5%) | 0/86 (0%) | ||
| Ejaculation failure | 0/81 (0%) | 1/86 (1.2%) | ||
| Epididymitis | 0/81 (0%) | 1/86 (1.2%) | ||
| Erectile dysfunction | 0/81 (0%) | 2/86 (2.3%) | ||
| Galactorrhoea | 2/81 (2.5%) | 0/86 (0%) | ||
| Painful erection | 1/81 (1.2%) | 0/86 (0%) | ||
| Pelvic discomfort | 0/81 (0%) | 1/86 (1.2%) | ||
| Sexual dysfunction | 1/81 (1.2%) | 2/86 (2.3%) | ||
| Testicular disorder | 0/81 (0%) | 1/86 (1.2%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 3/81 (3.7%) | 0/86 (0%) | ||
| Cough | 6/81 (7.4%) | 2/86 (2.3%) | ||
| Dyspnoea | 2/81 (2.5%) | 0/86 (0%) | ||
| Epistaxis | 1/81 (1.2%) | 0/86 (0%) | ||
| Hiccups | 0/81 (0%) | 1/86 (1.2%) | ||
| Nasal congestion | 3/81 (3.7%) | 0/86 (0%) | ||
| Oropharyngeal pain | 4/81 (4.9%) | 1/86 (1.2%) | ||
| Pleural effusion | 1/81 (1.2%) | 0/86 (0%) | ||
| Sleep apnoea syndrome | 1/81 (1.2%) | 0/86 (0%) | ||
| Throat irritation | 1/81 (1.2%) | 0/86 (0%) | ||
| Upper respiratory tract congestion | 1/81 (1.2%) | 0/86 (0%) | ||
| Wheezing | 0/81 (0%) | 1/86 (1.2%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Acne | 2/81 (2.5%) | 1/86 (1.2%) | ||
| Alopecia | 1/81 (1.2%) | 0/86 (0%) | ||
| Blister | 1/81 (1.2%) | 0/86 (0%) | ||
| Dry skin | 1/81 (1.2%) | 0/86 (0%) | ||
| Erythema | 0/81 (0%) | 1/86 (1.2%) | ||
| Pruritus | 4/81 (4.9%) | 1/86 (1.2%) | ||
| Skin discomfort | 1/81 (1.2%) | 0/86 (0%) | ||
| Swelling face | 0/81 (0%) | 2/86 (2.3%) | ||
| Social circumstances | ||||
| Verbal abuse | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Surgical and medical procedures | ||||
| Cholecystectomy | 1/81 (1.2%) | 0/86 (0%) | ||
| Removal of foreign body | 0/81 (0%) | 1/86 (1.2%) | ||
| Rhinoplasty | 1/81 (1.2%) | 0/86 (0%) | ||
| Surgery | 1/81 (1.2%) | 1/86 (1.2%) | ||
| Tooth extraction | 2/81 (2.5%) | 1/86 (1.2%) | ||
| Vascular disorders | ||||
| Hot flush | 0/81 (0%) | 1/86 (1.2%) | ||
| Hypertension | 3/81 (3.7%) | 1/86 (1.2%) | ||
| Hypotension | 2/81 (2.5%) | 0/86 (0%) | ||
Limitations/Caveats
The study was terminated due to futility.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Director Medical Affairs - CNS |
|---|---|
| Organization | Janssen Inc. Toronto, Ontario, Canada |
| Phone | +1-416-382-5094 |
Responsible Party:
Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:
NCT00256997
Other Study ID Numbers:
- CR006016
- RISSCH4055
First Posted:
Nov 22, 2005
Last Update Posted:
Dec 5, 2013
Last Verified:
Nov 1, 2013