A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.

NCT00282464 | Completed Phase 3 Results DMC

• 1 other identifier: A1281139
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 43

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 Depression

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. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.

  Baseline to Week 6

Secondary Outcomes (21)

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

  Baseline to Week 6

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

  Baseline to Week 3, Week 6

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

  Week 1 to Week 6

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

  Week 3, Week 6

• Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score

  Baseline to Weeks 3, 6

Study Arms (2)

Ziprasidone 20 and 60mg

ACTIVE COMPARATOR

For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).

Drug: Geodon (Ziprasidone)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.

Placebo

Geodon (Ziprasidone) DRUG

Ziprasidone flexible dosing treatment arm (20-80 mg bid). For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).

Ziprasidone 20 and 60mg

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 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 NOS (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 (43)

Pfizer Investigational Site

Dothan, Alabama, 36303, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 77205, United States

Location

Pfizer Investigational Site

Anaheim, California, 92804, United States

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Cerritos, California, 90703, United States

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Chula Vista, California, 91910, United States

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Escondido, California, 92025, United States

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Los Angeles, California, 90027-5302, United States

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Riverside, California, 92506, United States

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San Diego, California, 92126, United States

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Santa Ana, California, 92705, United States

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Denver, Colorado, 80220, United States

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Darien, Connecticut, 06820, United States

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Boca Raton, Florida, 33432, United States

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Bradenton, Florida, 34208, United States

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Jacksonville, Florida, 32256-2006, United States

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Melbourne, Florida, 32901, United States

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Orange City, Florida, 32763, United States

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Tampa, Florida, 33613, United States

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Atlanta, Georgia, 30328, United States

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Marietta, Georgia, 30060, United States

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Eagle, Idaho, 83616, United States

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Granite City, Illinois, 62040-4749, United States

Location

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Terre Haute, Indiana, 47802, United States

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Glen Burnie, Maryland, 21061, United States

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Towson, Maryland, 21204, United States

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Rochester, Minnesota, 55905, United States

Location

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St Louis, Missouri, 63118, United States

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Princeton, New Jersey, 08540, United States

Location

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Brooklyn, New York, 11223, United States

Location

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Brooklyn, New York, 11235, United States

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New York, New York, 10003, United States

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Olean, New York, 14760, United States

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Durham, North Carolina, 27704, United States

Location

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Raleigh, North Carolina, 27609, United States

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Toledo, Ohio, 43623, United States

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Tulsa, Oklahoma, 74135, United States

Location

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Philadelphia, Pennsylvania, 19149, United States

Location

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Scranton, Pennsylvania, 18503, United States

Location

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Lincoln, Rhode Island, 02865, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

Houston, Texas, 77007, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Charlottesville, Virginia, 22903-4895, United States

Location

Related Publications (1)

• 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: January 24, 2006
• First Posted: January 26, 2006
• Study Start: February 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 29, 2021
• Results First Posted: June 2, 2009

Record last verified: 2021-03

Locations

US (43)