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
NCT number | NCT00280566 |
Other study ID # | A1281137 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | December 2005 |
Est. completion date | May 2008 |
Verified date | March 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States, Venezuela, Chile, France, Germany, Guatemala, Hong Kong, India, Italy, Mexico, Russian Federation, Spain, Taiwan,
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 |
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