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

NCT00280566 | Completed Phase 3 Results

• 1 other identifier: A1281137
• Study Type: interventional
• Target: 584
• Locations: 13 countries
• Sites: 107

Brief 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.

Conditions

Bipolar Mania; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Time to Discontinuation for Any Reason During Double Blind Period 2

  Period 2: 24 weeks or time of early termination

• Modified Time to Intervention for a Mood Episode (TIME)

  Period 2: Week 24 or time of early termination

• Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period

  Period 2: Weeks 1 - 24 or time of early termination

• Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period

  Period 2: Weeks 1 - 24 or time of early termination

• Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period

  Period 2: Weeks 1 - 24 or time of early termination

Study Arms (2)

Ziprasidone

EXPERIMENTAL

Active treatment, double-blind, randomized arm

Drug: Ziprasidone Oral Capsule

Placebo

PLACEBO COMPARATOR

Placebo treatment, double-blind, randomized arm

Drug: Placebo

Interventions

Placebo DRUG

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.

Placebo

Ziprasidone Oral Capsule DRUG

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.

Also known as: Geodon, Zeldox

Ziprasidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)

You may not qualify if:

• Ultra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (107)

Pfizer Investigational Site

Birmingham, Alabama, 35226, United States

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Birmingham, Alabama, 35294, United States

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Birmingham, Alabama, 35924, United States

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Scottsdale, Arizona, 85251, United States

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Little Rock, Arkansas, 72223, United States

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Costa Mesa, California, 92626, United States

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Los Angeles, California, 90026, United States

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National City, California, 91950, United States

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Sacramento, California, 95823, United States

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San Diego, California, 92108, United States

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Temecula, California, 92590, United States

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Temecula, California, 92591, United States

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Altamonte Springs, Florida, 32701, United States

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Fort Lauderdale, Florida, 33319, United States

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Fort Myers, Florida, 33912, United States

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Jacksonville, Florida, 32216, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33016, United States

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Miami, Florida, 33126, United States

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North Miami, Florida, 33161, United States

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Orlando, Florida, 32806, United States

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Tavares, Florida, 32778, United States

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Decatur, Georgia, 30033, United States

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Smyrna, Georgia, 30080, United States

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Honolulu, Hawaii, 96826, United States

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Des Plaines, Illinois, 60016, United States

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Libertyville, Illinois, 60048, United States

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Naperville, Illinois, 60540, United States

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Naperville, Illinois, 60563, United States

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Oak Brook, Illinois, 60523, United States

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Schaumburg, Illinois, 60194, United States

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Terre Haute, Indiana, 47802, United States

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Topeka, Kansas, 66606, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40509, United States

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Owensboro, Kentucky, 42301, United States

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Baltimore, Maryland, 21285, United States

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Rockville, Maryland, 20852, United States

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Pittsfield, Massachusetts, 01201, United States

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Taunton, Massachusetts, 02780, United States

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Olive Branch, Mississippi, 38654, United States

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Ridgeland, Mississippi, 39157, United States

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Saint Charles, Missouri, 63301, United States

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Lincoln, Nebraska, 68506, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89106, United States

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Nashua, New Hampshire, 03060, United States

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Paramus, New Jersey, 07652, United States

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Teaneck, New Jersey, 07666, United States

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Buffalo, New York, 14215, United States

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Olean, New York, 14760, United States

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Rochester, New York, 14618, United States

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Raleigh, North Carolina, 27609, United States

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Cincinnati, Ohio, 45267-0559, United States

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Columbus, Ohio, 43210, United States

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Toledo, Ohio, 43609, United States

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Bethany, Oklahoma, 73008, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73116, United States

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Media, Pennsylvania, 19063, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Memphis, Tennessee, 38117, United States

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Arlington, Texas, 76012, United States

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Austin, Texas, 78756, United States

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Bellaire, Texas, 77401, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75390-9121, United States

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DeSoto, Texas, 75115, United States

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Houston, Texas, 77008, United States

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Houston, Texas, 77054, United States

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Houston, Texas, 77057, United States

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Santiago, RM, Chile

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Santiago, Chile

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Angoulême, 16000, France

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Brest Naval, 29240, France

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Douai, 59500, France

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Mulhouse, 68100, France

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Berlin, 13509, Germany

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Berlin, 14050, Germany

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Cham, 93413, Germany

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Essen, 45136, Germany

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Guatemala City, Guatemala

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New Territories, Hong Kong

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Ellisbridge, Ahmedabad, 380 006, India

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Tirupati, Andhra Pradesh, 517 507, India

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Bangalore, Karnataka, 560 010, India

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Mysore, Karnataka, 570004, India

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Chennai, Tamil Nadu, 600 003, India

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Ludhiana, 141001, India

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Pune, 411 030, India

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Catania, 95123, Italy

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Florence, 50134, Italy

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Parma, 43100, Italy

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Pisa, 56126, Italy

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Zapopan, Jalisco, 45200, Mexico

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Mexico City, Mexico City, 03740, Mexico

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Arkhangelskaya Obl, Primorsky Raion, 163530, Russia

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Khot'kovo, 141371, Russia

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Barcelona, 08019, Spain

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Barcelona, 08036, Spain

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Madrid, 28007, Spain

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Taipei, 110, Taiwan

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Taipei, 112, Taiwan

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Caracas, Distrito Federal, 1010, Venezuela

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Pfizer Investigational Site

Caracas, Distrito Federal, 1050, Venezuela

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Related Publications (1)

• Bowden CL, Vieta E, Ice KS, Schwartz JH, Wang PP, Versavel M. Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial. J Clin Psychiatry. 2010 Feb;71(2):130-7. doi: 10.4088/JCP.09m05482yel. Epub 2010 Jan 26.

  PMID: 20122373 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Limitations and Caveats

This is a maintenance of effect design using a survival analysis methodology. In such a design it may be difficult to interpret timepoint by timepoint treatment group comparisons in MRS, CGI-S, CGI-I, MADRS, and PANSS.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2006
• First Posted: January 23, 2006
• Study Start: December 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 25, 2021
• Results First Posted: December 14, 2009

Record last verified: 2021-03

Locations

DE (4); FR (4); HK (1); IN (7); RU (2); GU (1); VE (2); US (73); CL (2); IT (4); TW (2); ES (3); ME (2)