Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)

Bipolar Disorder Clinical Trial

Official title:

A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280566
• Other study ID #: A1281137
• Status: Completed
• Phase: Phase 3
• Start date: December 2005
• Est. completion date: May 2008

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms) Exclusion Criteria: Ultra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Mania

Intervention

Drug:
• Placebo
Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.
• Ziprasidone Oral Capsule
Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.

Locations

Country	Name	City	State
Chile	Pfizer Investigational Site	Santiago	RM
Chile	Pfizer Investigational Site	Santiago
France	Pfizer Investigational Site	Angouleme
France	Pfizer Investigational Site	Brest Naval
France	Pfizer Investigational Site	Douai
France	Pfizer Investigational Site	Mulhouse
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Cham
Germany	Pfizer Investigational Site	Essen
Guatemala	Pfizer Investigational Site	Ciudad de Guatemala
Guatemala	Pfizer Investigational Site	Guatemala
Hong Kong	Pfizer Investigational Site	New Territories
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Chennai	Tamil Nadu
India	Pfizer Investigational Site	Ellisbridge	Ahmedabad
India	Pfizer Investigational Site	Ludhiana
India	Pfizer Investigational Site	Mysore	Karnataka
India	Pfizer Investigational Site	Pune
India	Pfizer Investigational Site	Tirupati	Andhra Pradesh
Italy	Pfizer Investigational Site	Catania
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Parma
Italy	Pfizer Investigational Site	Pisa
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	Zapopan	Jalisco
Russian Federation	Pfizer Investigational Site	Arkhangelskaya Obl, Primorsky Raion
Russian Federation	Pfizer Investigational Site	Khotkovo
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Madrid
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
United States	Pfizer Investigational Site	Altamonte Springs	Florida
United States	Pfizer Investigational Site	Arlington	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bellaire	Texas
United States	Pfizer Investigational Site	Bethany	Oklahoma
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Costa Mesa	California
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Des Plaines	Illinois
United States	Pfizer Investigational Site	DeSoto	Texas
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Fort Myers	Florida
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Libertyville	Illinois
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Maitland	Florida
United States	Pfizer Investigational Site	Media	Pennsylvania
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Naperville	Illinois
United States	Pfizer Investigational Site	Naperville	Illinois
United States	Pfizer Investigational Site	Nashua	New Hampshire
United States	Pfizer Investigational Site	National City	California
United States	Pfizer Investigational Site	North Miami	Florida
United States	Pfizer Investigational Site	Oak Brook	Illinois
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Olean	New York
United States	Pfizer Investigational Site	Olive Branch	Mississippi
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Owensboro	Kentucky
United States	Pfizer Investigational Site	Paramus	New Jersey
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsfield	Massachusetts
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Ridgeland	Mississippi
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Rockville	Maryland
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Saint Charles	Missouri
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Schaumburg	Illinois
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Smyrna	Georgia
United States	Pfizer Investigational Site	Taunton	Massachusetts
United States	Pfizer Investigational Site	Tavares	Florida
United States	Pfizer Investigational Site	Teaneck	New Jersey
United States	Pfizer Investigational Site	Temecula	California
United States	Pfizer Investigational Site	Temecula	California
United States	Pfizer Investigational Site	Terre Haute	Indiana
United States	Pfizer Investigational Site	Toledo	Ohio
United States	Pfizer Investigational Site	Topeka	Kansas
United States	Pfizer Investigational Site	Wichita	Kansas
Venezuela	Pfizer Investigational Site	Caracas	Distrito Capital
Venezuela	Pfizer Investigational Site	Caracas	Distrito Capital

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Venezuela,  Chile,  France,  Germany,  Guatemala,  Hong Kong,  India,  Italy,  Mexico,  Russian Federation,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Intervention for a Mood Episode During Double Blind Period	Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is =18 for 2 consecutive visits scheduled no more than 10 days apart.	Period 2: 24 weeks or time of early termination
Secondary	Time to Discontinuation for Any Reason During Double Blind Period 2	Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.	Period 2: 24 weeks or time of early termination
Secondary	Modified Time to Intervention for a Mood Episode (TIME)	Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is =18 for 2 consecutive visits scheduled no more than 10 days apart.	Period 2: Week 24 or time of early termination
Secondary	Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period	Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.	Period 2: Weeks 1 - 24 or time of early termination
Secondary	Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period	Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.	Period 2: Weeks 1 - 24 or time of early termination
Secondary	Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period	Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse.	Period 2: Weeks 1 - 24 or time of early termination
Secondary	Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period	Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.	Period 2: Weeks 1 - 24 or time of early termination
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period	Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)	Period 2: Weeks 4 - 24 or time of early termination
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period	Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme).	Period 2: Weeks 4 - 24 or time of early termination
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period	Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).	Period 2: Weeks 4 - 24 or time of early termination

External Links

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