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

NCT00141271 | Completed Phase 3 Results DMC

• 1 other identifier: A1281136
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 72

Brief Summary

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.

Conditions

Bipolar Disorder

Keywords

Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score

  Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.

  Baseline to 6 weeks

Secondary Outcomes (37)

• Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score

  Baseline to 6 weeks

• Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score

  Baseline to 6 weeks

• Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)

  Baseline, 6 Weeks LOCF

• Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12

  Baseline to 6 weeks

• Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7

  Baseline to 6 weeks

Study Arms (3)

20-40mg BID arm

ACTIVE COMPARATOR

Drug: Geodon (Ziprasidone)

60-80mg bid arm

ACTIVE COMPARATOR

Drug: Geodon (Ziprasidone)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Geodon (Ziprasidone) 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

20-40mg BID arm

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (72)

Pfizer Investigational Site

Birmingham, Alabama, 35209, United States

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Dana Point, California, 92629, United States

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La Mesa, California, 91942, United States

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Laguna Hills, California, 92653, United States

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Oceanside, California, 92056, United States

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Orange, California, 92868, United States

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San Diego, California, 92108, United States

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San Diego, California, 92120, United States

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Santa Ana, California, 92705, United States

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Torrance, California, 90505, United States

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Fort Lauderdale, Florida, 33319, United States

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Gainesville, Florida, 32607, United States

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Hialeah, Florida, 33016, United States

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Jacksonville, Florida, 32216, 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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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30308, United States

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Maywood, Illinois, 60153, United States

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Naperville, Illinois, 60563, United States

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Schaumburg, Illinois, 60194, United States

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Greenwood, Indiana, 46143, United States

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Lafayette, Indiana, 47905, United States

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Prarie Village, Kansas, 66206, United States

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New Orleans, Louisiana, 70114, United States

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Shreveport, Louisiana, 71101, United States

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Shreveport, Louisiana, 71105, United States

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Boston, Massachusetts, 02114, United States

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Worcester, Massachusetts, 01605, United States

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Minneapolis, Minnesota, 55454, United States

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Flowood, Mississippi, 39232, United States

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St Louis, Missouri, 63128, United States

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St Louis, Missouri, 63144, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89102, United States

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Clementon, New Jersey, 08021, United States

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Toms River, New Jersey, 08755, United States

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New York, New York, 10021, United States

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Staten Island, New York, 10305, United States

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Cincinnati, Ohio, 45267-0001, United States

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Cleveland, Ohio, 44106, United States

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Cleveland, Ohio, 44113, United States

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Mayfield, Ohio, 44143, United States

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Oklahoma City, Oklahoma, 73118, United States

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Philadelphia, Pennsylvania, 19131, United States

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Philadelphia, Pennsylvania, 19149, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Charleston, South Carolina, 29425, United States

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Columbia, South Carolina, 29201, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37203-1515, United States

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Bellaire, Texas, 77401, United States

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Dallas, Texas, 75216, United States

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Dallas, Texas, 75234, United States

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DeSoto, Texas, 75115, United States

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Galveston, Texas, 77555-0188, United States

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Houston, Texas, 77555, United States

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Irving, Texas, 75062, United States

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Plano, Texas, 75093, United States

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Richardson, Texas, 75080, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78284-7792, United States

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Wichita Falls, Texas, 76309, United States

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Arlington, Virginia, 22201, United States

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Falls Church, Virginia, 22041, United States

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Richmond, Virginia, 23229, United States

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Richmond, Virginia, 23230, United States

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Virginia Beach, Virginia, 23452, United States

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Kirkland, Washington, 98033, United States

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Milwaukee, Wisconsin, 53226, United States

Location

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Milwaukee, Wisconsin, 53227, United States

Location

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West Allis, Wisconsin, 53227, United States

Location

Related Publications (2)

• 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.

  PMID: 25012414 DERIVED

• 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.

  PMID: 23609405 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

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: July 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 25, 2021
• Results First Posted: March 24, 2009

Record last verified: 2021-03

Locations

US (72)