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

NCT ID: NCT00280566

Last Updated: 2021-03-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

584 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar Mania Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ziprasidone

Active treatment, double-blind, randomized arm

Group Type EXPERIMENTAL

Ziprasidone Oral Capsule

Intervention Type 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.

Placebo

Placebo treatment, double-blind, randomized arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Geodon, Zeldox

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Costa Mesa, California, United States

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Los Angeles, California, United States

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National City, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Temecula, California, United States

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Temecula, California, United States

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Altamonte Springs, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Tavares, Florida, United States

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Decatur, Georgia, United States

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Smyrna, Georgia, United States

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Honolulu, Hawaii, United States

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Des Plaines, Illinois, United States

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Libertyville, Illinois, United States

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Naperville, Illinois, United States

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Naperville, Illinois, United States

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Oak Brook, Illinois, United States

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Schaumburg, Illinois, United States

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Terre Haute, Indiana, United States

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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Owensboro, Kentucky, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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Pittsfield, Massachusetts, United States

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Taunton, Massachusetts, United States

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Olive Branch, Mississippi, United States

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Ridgeland, Mississippi, United States

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Saint Charles, Missouri, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Nashua, New Hampshire, United States

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Paramus, New Jersey, United States

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Teaneck, New Jersey, United States

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Buffalo, New York, United States

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Olean, New York, United States

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Rochester, New York, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Bethany, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Media, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Memphis, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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DeSoto, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Santiago, RM, Chile

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Santiago, , Chile

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Angoulême, , France

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Brest Naval, , France

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Douai, , France

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Mulhouse, , France

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Berlin, , Germany

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Berlin, , Germany

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Cham, , Germany

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Essen, , Germany

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Guatemala City, , Guatemala

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New Territories, , Hong Kong

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Ellisbridge, Ahmedabad, India

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Tirupati, Andhra Pradesh, India

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Bangalore, Karnataka, India

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Mysore, Karnataka, India

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Chennai, Tamil Nadu, India

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Ludhiana, , India

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Pune, , India

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Catania, , Italy

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Florence, , Italy

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Parma, , Italy

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Pisa, , Italy

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Zapopan, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Arkhangelskaya Obl, Primorsky Raion, , Russia

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Khot'kovo, , Russia

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Taipei, , Taiwan

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Taipei, , Taiwan

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Caracas, Distrito Federal, Venezuela

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Caracas, Distrito Federal, Venezuela

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Countries

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United States Chile France Germany Guatemala Hong Kong India Italy Mexico Russia Spain Taiwan Venezuela

References

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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.

Reference Type DERIVED
PMID: 20122373 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281137&StudyName=Safety%20and%20Maintenance%20of%20Effect%20of%20Ziprasidone%20Plus%20a%20Mood%20Stabilizer%20in%20Bipolar%20I%20Disorder%20%28manic%20or%20mixed%29

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

Other Identifiers

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A1281137

Identifier Type: -

Identifier Source: org_study_id

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