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A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression

NCT ID: NCT00141271

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

536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-02-29

Brief Summary

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This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are required to undergo a washout period of at least 7 days of any prior med.

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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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20-40mg BID arm

Group Type ACTIVE_COMPARATOR

Geodon (Ziprasidone)

Intervention Type DRUG

Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial

60-80mg bid arm

Group Type ACTIVE_COMPARATOR

Geodon (Ziprasidone)

Intervention Type DRUG

Subjects will start at 20mg bid days 1-2, then 40mg bid days 3-4, them 60mg bid for days 5-6 then flexible dosing starting on day 7 between 60-80mg bid (60 mg bid or 80mg bid) for the remainder of the 6 week trial

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial

Interventions

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Geodon (Ziprasidone)

Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial

Intervention Type DRUG

Geodon (Ziprasidone)

Subjects will start at 20mg bid days 1-2, then 40mg bid days 3-4, them 60mg bid for days 5-6 then flexible dosing starting on day 7 between 60-80mg bid (60 mg bid or 80mg bid) for the remainder of the 6 week trial

Intervention Type DRUG

Placebo

Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in Diagnostic and Statistical Manual (of Mental Disorders) - Fourth Edition - Text Revision (DSM-IV-TR) (296.5X) and confirmed by a structured Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria

* Subjects with a DSM-IV TR diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (298.9).
* Subjects with other DSM-IV TR Axis I or Axis II disorder (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6 month period prior to screening.
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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Dana Point, California, United States

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La Mesa, California, United States

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Laguna Hills, California, United States

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Oceanside, California, United States

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Orange, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Torrance, California, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Maywood, Illinois, United States

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Naperville, Illinois, United States

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Schaumburg, Illinois, United States

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Greenwood, Indiana, United States

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Lafayette, Indiana, United States

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Prarie Village, Kansas, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Shreveport, Louisiana, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Flowood, Mississippi, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Clementon, New Jersey, United States

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Toms River, New Jersey, United States

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New York, New York, United States

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Staten Island, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Mayfield, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, 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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Galveston, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Plano, Texas, United States

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Richardson, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Arlington, Virginia, United States

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Falls Church, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Kirkland, Washington, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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West Allis, Wisconsin, United States

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Countries

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United States

References

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Keefe RS, Fox KH, Davis VG, Kennel C, Walker TM, Burdick KE, Harvey PD. The Brief Assessment of Cognition In Affective Disorders (BAC-A):performance of patients with bipolar depression and healthy controls. J Affect Disord. 2014 Sep;166:86-92. doi: 10.1016/j.jad.2014.05.002. Epub 2014 May 11.

Reference Type DERIVED
PMID: 25012414 (View on PubMed)

Gao K, Pappadopulos E, Karayal ON, Kolluri S, Calabrese JR. Risk for adverse events and discontinuation due to adverse events of ziprasidone monotherapy relative to placebo in the acute treatment of bipolar depression, mania, and schizophrenia. J Clin Psychopharmacol. 2013 Jun;33(3):425-31. doi: 10.1097/JCP.0b013e3182917f3f.

Reference Type DERIVED
PMID: 23609405 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281136&StudyName=A%20Six-Week%20Study%20Evaluating%20The%20Efficacy%20And%20Safety%20Of%20Geodon%20In%20Patients%20With%20A%20Diagnosis%20Of%20Bipolar%20I%20Depression

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

Other Identifiers

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A1281136

Identifier Type: -

Identifier Source: org_study_id

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