ZOOM: Ziprasidone And Olanzapine's Outcomes In Mania
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania. An open label extension will further evaluate the efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007. Subjects that were enrolled at the time completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was January 10, 2008.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: A
|
Drug: ziprasidone hydrochloride
Ziprasidone will be initiated at 80 mg/day on Day 1 and titrated to 120 mg/day from Day 3. From Day 7 the dosage may be adjusted on the basis of clinical status between 120 and 160 mg/day.
Other Names:
|
Active Comparator: B
|
Drug: olanzapine
Olanzapine will be started at 15 mg/day on Day 1 until Day 7. The dosage will then be adjusted on the basis of clinical status between 15 and 20 mg/day.
|
Outcome Measures
Primary Outcome Measures
- Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase. [4 weeks]
YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.
Secondary Outcome Measures
- Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase. [up to 10 weeks]
- Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase. [6 months]
- Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase. [4, 6 and 10 weeks]
- Time to Symptomatic Remission in the Double Blind Phase. [up to 10 weeks]
- Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment. [6 weeks]
- Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase. [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have a primary diagnosis of Bipolar I Disorder, current episode manic (DSM-IV 296.4x) or mixed (DSM-IV296.6x) as determined by a structured clinical interview (Mini International Neuropsychiatric Interview (MINI)) at screening.
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A minimum score of 20 on the YMRS (Youngs Mania Rating Scale).
Exclusion Criteria:
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Have a diagnosis of learning disability or organic brain syndrome.
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Have a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Pfizer Investigational Site | Aachen | Germany | 52074 | |
2 | Pfizer Investigational Site | Augsburg | Germany | 86156 | |
3 | Pfizer Investigational Site | Freiburg | Germany | 79104 | |
4 | Pfizer Investigational Site | Athens | Greece | 124 62 | |
5 | Pfizer Investigational Site | S. Arsenio | Salerno | Italy | 84037 |
6 | Pfizer Investigational Site | Bari | Italy | 70100 | |
7 | Pfizer Investigational Site | Guardiagrele (CH) | Italy | 66016 | |
8 | Pfizer Investigational Site | Lido Di Camaiore (LU) | Italy | 55043 | |
9 | Pfizer Investigational Site | Partinico (Pa) | Italy | 90047 | |
10 | Pfizer Investigational Site | Perugia | Italy | 06127 | |
11 | Pfizer Investigational Site | Siena | Italy | 53100 | |
12 | Pfizer Investigational Site | Torino | Italy | 10126 | |
13 | Pfizer Investigational Site | Trieste | Italy | 34126 | |
14 | Pfizer Investigational Site | Terrassa | Barcelona | Spain | 08227 |
15 | Pfizer Investigational Site | Alava | Vitoria | Spain | 01004 |
16 | Pfizer Investigational Site | Granada | Spain | 18014 | |
17 | Pfizer Investigational Site | Malaga | Spain | 29009 | |
18 | Pfizer Investigational Site | Ankara | Turkey | 06100 | |
19 | Pfizer Investigational Site | Istanbul | Turkey | 34440 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A1281147
Study Results
Participant Flow
Recruitment Details | 47 centers in Europe. |
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Pre-assignment Detail | After a wash out period of at least 24 hours, patients were randomized to ziprasidone or olanzapine. |
Arm/Group Title | Ziprasidone | Olanzapine |
---|---|---|
Arm/Group Description | Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion. | Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion. |
Period Title: Overall Study | ||
STARTED | 15 | 14 |
COMPLETED | 5 | 2 |
NOT COMPLETED | 10 | 12 |
Baseline Characteristics
Arm/Group Title | Ziprasidone | Olanzapine | Total |
---|---|---|---|
Arm/Group Description | Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion. | Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion. | Total of all reporting groups |
Overall Participants | 15 | 14 | 29 |
Age, Customized (participants) [Number] | |||
18-44 years |
9
60%
|
7
50%
|
16
55.2%
|
45-64 years |
6
40%
|
7
50%
|
13
44.8%
|
Sex: Female, Male (Count of Participants) | |||
Female |
10
66.7%
|
5
35.7%
|
15
51.7%
|
Male |
5
33.3%
|
9
64.3%
|
14
48.3%
|
Outcome Measures
Title | Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase. |
---|---|
Description | YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item. |
Time Frame | 4 weeks |
Outcome Measure Data
Analysis Population Description |
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Study was terminated due to poor recruitment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. |
Arm/Group Title | Ziprasidone | Olanzapine |
---|---|---|
Arm/Group Description | Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion. | Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion. |
Measure Participants | 0 | 0 |
Title | Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase. |
---|---|
Description | |
Time Frame | up to 10 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase. |
---|---|
Description | |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase. |
---|---|
Description | |
Time Frame | 4, 6 and 10 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Time to Symptomatic Remission in the Double Blind Phase. |
---|---|
Description | |
Time Frame | up to 10 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment. |
---|---|
Description | |
Time Frame | 6 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase. |
---|---|
Description | |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Ziprasidone | Olanzapine | ||
Arm/Group Description | Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion. | Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion. | ||
All Cause Mortality |
||||
Ziprasidone | Olanzapine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Ziprasidone | Olanzapine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/ (NaN) | 0/ (NaN) | ||
Eye disorders | ||||
Oculogyric crisis | 1/15 (6.7%) | 0/14 (0%) | ||
General disorders | ||||
Disease progression | 1/15 (6.7%) | 0/14 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
laryngospasm | 1/15 (6.7%) | 0/14 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Ziprasidone | Olanzapine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 7/ (NaN) | 12/ (NaN) | ||
Blood and lymphatic system disorders | ||||
Anemia | 0/15 (0%) | 1/14 (7.1%) | ||
Endocrine disorders | ||||
Hyperprolactinaemia | 0/15 (0%) | 1/14 (7.1%) | ||
Gastrointestinal disorders | ||||
Dry mouth | 0/15 (0%) | 2/14 (14.3%) | ||
flatulence | 0/15 (0%) | 1/14 (7.1%) | ||
gingivitis | 0/15 (0%) | 1/14 (7.1%) | ||
nausea | 1/15 (6.7%) | 1/14 (7.1%) | ||
vomiting | 1/15 (6.7%) | 1/14 (7.1%) | ||
General disorders | ||||
fatigue | 0/15 (0%) | 2/14 (14.3%) | ||
pyrexia | 0/15 (0%) | 1/14 (7.1%) | ||
Immune system disorders | ||||
hypersensitivity | 0/15 (0%) | 1/14 (7.1%) | ||
Infections and infestations | ||||
nasopharyngitis | 0/15 (0%) | 1/14 (7.1%) | ||
pneumonia bacterial | 0/15 (0%) | 1/14 (7.1%) | ||
tonsillitis | 0/15 (0%) | 1/14 (7.1%) | ||
Injury, poisoning and procedural complications | ||||
joint dislocation | 0/15 (0%) | 1/14 (7.1%) | ||
Investigations | ||||
weight increased | 1/15 (6.7%) | 1/14 (7.1%) | ||
Metabolism and nutrition disorders | ||||
fluid retention | 0/15 (0%) | 1/14 (7.1%) | ||
hyperlipidaemia | 0/15 (0%) | 1/14 (7.1%) | ||
increased appetite | 0/15 (0%) | 2/14 (14.3%) | ||
Nervous system disorders | ||||
headache | 1/15 (6.7%) | 1/14 (7.1%) | ||
hypotonia | 0/15 (0%) | 1/14 (7.1%) | ||
somnolence | 3/15 (20%) | 1/14 (7.1%) | ||
tremor | 1/15 (6.7%) | 3/14 (21.4%) | ||
Psychiatric disorders | ||||
anxiety | 1/15 (6.7%) | 1/14 (7.1%) | ||
binge eating | 0/15 (0%) | 1/14 (7.1%) | ||
delusion | 0/15 (0%) | 1/14 (7.1%) | ||
depressed mood | 1/15 (6.7%) | 0/14 (0%) | ||
depression | 0/15 (0%) | 1/14 (7.1%) | ||
insomnia | 2/15 (13.3%) | 0/14 (0%) | ||
mania | 1/15 (6.7%) | 0/14 (0%) | ||
Reproductive system and breast disorders | ||||
breast enlargement | 0/15 (0%) | 1/14 (7.1%) | ||
sexual dysfunction | 0/15 (0%) | 1/14 (7.1%) | ||
Skin and subcutaneous tissue disorders | ||||
eczema | 0/15 (0%) | 1/14 (7.1%) | ||
hyperhidrosis | 0/15 (0%) | 1/14 (7.1%) | ||
Surgical and medical procedures | ||||
tooth extraction | 0/15 (0%) | 1/14 (7.1%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer, Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.govCallCenter@pfizer.com |
- A1281147