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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Mania; Bipolar Disorder

Intervention: Placebo (Drug); Ziprasidone Oral Capsule (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to Intervention for a Mood Episode During Double Blind Period

Secondary outcome:

Time to Discontinuation for Any Reason During Double Blind Period 2

Modified Time to Intervention for a Mood Episode (TIME)

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

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

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

Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Pfizer Investigational Site, Santiago, Chile

Pfizer Investigational Site, Angouleme 16000, France

Pfizer Investigational Site, Brest Naval 29240, France

Pfizer Investigational Site, Douai 59500, France

Pfizer Investigational Site, Mulhouse 68100, France

Pfizer Investigational Site, Berlin 13509, Germany

Pfizer Investigational Site, Berlin 14050, Germany

Pfizer Investigational Site, Cham 93413, Germany

Pfizer Investigational Site, Essen 45136, Germany

Pfizer Investigational Site, Ciudad de Guatemala, Guatemala

Pfizer Investigational Site, Guatemala, Guatemala

Pfizer Investigational Site, New Territories, Hong Kong

Pfizer Investigational Site, Ludhiana 141001, India

Pfizer Investigational Site, Pune 411 030, India

Pfizer Investigational Site, Catania 95123, Italy

Pfizer Investigational Site, Firenze 50134, Italy

Pfizer Investigational Site, Parma 43100, Italy

Pfizer Investigational Site, Pisa 56126, Italy

Pfizer Investigational Site, Arkhangelskaya Obl, Primorsky Raion 163530, Russian Federation

Pfizer Investigational Site, Khotkovo 141371, Russian Federation

Pfizer Investigational Site, Barcelona 08019, Spain

Pfizer Investigational Site, Barcelona 08036, Spain

Pfizer Investigational Site, Madrid 28007, Spain

Pfizer Investigational Site, Taipei 110, Taiwan

Pfizer Investigational Site, Taipei 112, Taiwan

Pfizer Investigational Site, Ellisbridge, Ahmedabad 380 006, India

Pfizer Investigational Site, Birmingham, Alabama 35226, United States

Pfizer Investigational Site, Birmingham, Alabama 35294, United States

Pfizer Investigational Site, Birmingham, Alabama 35924, United States

Pfizer Investigational Site, Tirupati, Andhra Pradesh 517 507, India

Pfizer Investigational Site, Scottsdale, Arizona 85251, United States

Pfizer Investigational Site, Little Rock, Arkansas 72223, United States

Pfizer Investigational Site, Costa Mesa, California 92626, United States

Pfizer Investigational Site, Los Angeles, California 90026, United States

Pfizer Investigational Site, National City, California 91950, United States

Pfizer Investigational Site, Sacramento, California 95823, United States

Pfizer Investigational Site, San Diego, California 92108, United States

Pfizer Investigational Site, Temecula, California 92590, United States

Pfizer Investigational Site, Temecula, California 92591, United States

Pfizer Investigational Site, Mexico, DF 03740, Mexico

Pfizer Investigational Site, Caracas, Distrito Capital 1010, Venezuela

Pfizer Investigational Site, Caracas, Distrito Capital 1050, Venezuela

Pfizer Investigational Site, Altamonte Springs, Florida 32701, United States

Pfizer Investigational Site, Fort Lauderdale, Florida 33319, United States

Pfizer Investigational Site, Fort Myers, Florida 33912, United States

Pfizer Investigational Site, Jacksonville, Florida 32216, United States

Pfizer Investigational Site, Maitland, Florida 32751, United States

Pfizer Investigational Site, Miami, Florida 33016, United States

Pfizer Investigational Site, Miami, Florida 33126, United States

Pfizer Investigational Site, North Miami, Florida 33161, United States

Pfizer Investigational Site, Orlando, Florida 32806, United States

Pfizer Investigational Site, Tavares, Florida 32778, United States

Pfizer Investigational Site, Decatur, Georgia 30033, United States

Pfizer Investigational Site, Smyrna, Georgia 30080, United States

Pfizer Investigational Site, Honolulu, Hawaii 96826, United States

Pfizer Investigational Site, Des Plaines, Illinois 60016, United States

Pfizer Investigational Site, Libertyville, Illinois 60048, United States

Pfizer Investigational Site, Naperville, Illinois 60563, United States

Pfizer Investigational Site, Naperville, Illinois 60540, United States

Pfizer Investigational Site, Oak Brook, Illinois 60523, United States

Pfizer Investigational Site, Schaumburg, Illinois 60194, United States

Pfizer Investigational Site, Terre Haute, Indiana 47802, United States

Pfizer Investigational Site, Zapopan, Jalisco 45200, Mexico

Pfizer Investigational Site, Topeka, Kansas 66606, United States

Pfizer Investigational Site, Wichita, Kansas 67207, United States

Pfizer Investigational Site, Bangalore, Karnataka 560 010, India

Pfizer Investigational Site, Mysore, Karnataka 570004, India

Pfizer Investigational Site, Lexington, Kentucky 40509, United States

Pfizer Investigational Site, Owensboro, Kentucky 42301, United States

Pfizer Investigational Site, Baltimore, Maryland 21285, United States

Pfizer Investigational Site, Rockville, Maryland 20852, United States

Pfizer Investigational Site, Pittsfield, Massachusetts 01201, United States

Pfizer Investigational Site, Taunton, Massachusetts 02780, United States

Pfizer Investigational Site, Olive Branch, Mississippi 38654, United States

Pfizer Investigational Site, Ridgeland, Mississippi 39157, United States

Pfizer Investigational Site, St. Charles, Missouri 63301, United States

Pfizer Investigational Site, Lincoln, Nebraska 68510, United States

Pfizer Investigational Site, Lincoln, Nebraska 68506, United States

Pfizer Investigational Site, Omaha, Nebraska 68131, United States

Pfizer Investigational Site, Las Vegas, Nevada 89106, United States

Pfizer Investigational Site, Nashua, New Hampshire 03060, United States

Pfizer Investigational Site, Paramus, New Jersey 07652, United States

Pfizer Investigational Site, Teaneck, New Jersey 07666, United States

Pfizer Investigational Site, Buffalo, New York 14215, United States

Pfizer Investigational Site, Olean, New York 14760, United States

Pfizer Investigational Site, Rochester, New York 14618, United States

Pfizer Investigational Site, Raleigh, North Carolina 27609, United States

Pfizer Investigational Site, Cincinnati, Ohio 45267-0559, United States

Pfizer Investigational Site, Columbus, Ohio 43210, United States

Pfizer Investigational Site, Toledo, Ohio 43609, United States

Pfizer Investigational Site, Bethany, Oklahoma 73008, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73103, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73116, United States

Pfizer Investigational Site, Media, Pennsylvania 19063, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15206, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15213, United States

Pfizer Investigational Site, Santiago, RM, Chile

Pfizer Investigational Site, Chennai, Tamil Nadu 600 003, India

Pfizer Investigational Site, Memphis, Tennessee 38117, United States

Pfizer Investigational Site, Arlington, Texas 76012, United States

Pfizer Investigational Site, Austin, Texas 78756, United States

Pfizer Investigational Site, Bellaire, Texas 77401, United States

Pfizer Investigational Site, Dallas, Texas 75231, United States

Pfizer Investigational Site, Dallas, Texas 75390-9121, United States

Pfizer Investigational Site, DeSoto, Texas 75115, United States

Pfizer Investigational Site, Houston, Texas 77008, United States

Pfizer Investigational Site, Houston, Texas 77054, United States

Pfizer Investigational Site, Houston, Texas 77057, United States

Additional Information

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

Starting date: December 2005
Last updated: January 5, 2010

Page last updated: August 23, 2015

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