Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia
Study Details
Study Description
Brief Summary
The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: SPD489 40mg
|
Drug: SPD489 40mg
Oral administration of 40 mg once-daily for up to 12 weeks
Other Names:
|
Experimental: SPD489 100mg
|
Drug: SPD489 100mg
Oral administration of 100 mg once-daily for up to 12 weeks
Other Names:
|
Experimental: SPD489 160mg
|
Drug: SPD489 160mg
Oral administration of 160 mg once-daily for up to 12 weeks
Other Names:
|
Placebo Comparator: Placebo
|
Drug: Placebo
Oral administration once-daily for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks [Baseline and 12 weeks]
Secondary Outcome Measures
- Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks [Baseline and 12 weeks]
- Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks [Baseline and 12 weeks]
- Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks [Baseline and 12 weeks]
- Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks [Baseline and 12 weeks]
- Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks [Baseline and 12 weeks]
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks [Baseline and 12 weeks]
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks [Baseline and 12 weeks]
- Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks [Baseline and 12 weeks]
- Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks [Baseline and 12 weeks]
- Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [Baseline and week 12]
- Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [Up to 12 weeks]
- Columbia-Suicide Severity Rating Scale (C-SSRS) [Up to 12 weeks]
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks [Baseline and 12 weeks]
- Ambulatory Blood Pressure Monitoring (ABPM) [Baseline and Weeks 4 and 10]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 to 65 years of age
-
Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
-
Fixed home/place of residence and can be reached by telephone
-
On a stable dose of antipsychotic medications
-
Able to swallow capsules
Exclusion Criteria:
-
Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
-
Treated with clozapine in past 30 days
-
Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
-
History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
-
Uncontrolled hypertension
-
History of thyroid disorder that has not been stabilized on thyroid medication
-
Glaucoma
-
Pregnant or nursing
-
Subject has received an investigational product or participated in a clinical study within 30 day
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Hills Clinical Research | Irving | Texas | United States | 75062 |
Sponsors and Collaborators
- Shire
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPD489-338
- 2012-003918-14
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Period Title: Overall Study | ||||
STARTED | 0 | 0 | 0 | 0 |
COMPLETED | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo | Total |
---|---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks | Total of all reporting groups |
Overall Participants | 0 | 0 | 0 | 0 | 0 |
Age () [] | |||||
<=18 years | |||||
Between 18 and 65 years | |||||
>=65 years | |||||
Sex: Female, Male () [] | |||||
Female | |||||
Male | |||||
Region of Enrollment () [] |
Outcome Measures
Title | Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale |
---|---|
Description | |
Time Frame | Baseline and week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale |
---|---|
Description | |
Time Frame | Up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Columbia-Suicide Severity Rating Scale (C-SSRS) |
---|---|
Description | |
Time Frame | Up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks |
---|---|
Description | |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Ambulatory Blood Pressure Monitoring (ABPM) |
---|---|
Description | |
Time Frame | Baseline and Weeks 4 and 10 |
Outcome Measure Data
Analysis Population Description |
---|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo |
---|---|---|---|---|
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks |
Measure Participants | 0 | 0 | 0 | 0 |
Adverse Events
Time Frame | ||||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | |||||||
Arm/Group Title | SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo | ||||
Arm/Group Description | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | Placebo: Oral administration once-daily for 12 weeks | ||||
All Cause Mortality |
||||||||
SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
SPD489 40mg | SPD489 100mg | SPD489 160mg | Placebo | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | Shire |
Phone | +1 866 842 5335 |
ClinicalTransparency@shire.com |
- SPD489-338
- 2012-003918-14