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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00282464
First received: January 24, 2006
Last updated: June 1, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Placebo
Drug: Geodon (Ziprasidone)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Six-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral Ziprasidone in Outpatients With Bipolar I Depression

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
  • Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score [ Time Frame: Baseline to Week 3, Week 6 ] [ Designated as safety issue: No ]
  • Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12 [ Time Frame: Week 1 to Week 6 ] [ Designated as safety issue: No ]
  • Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7 [ Time Frame: Week 3, Week 6 ] [ Designated as safety issue: No ]
  • Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score [ Time Frame: Baseline to Weeks 3, 6 ] [ Designated as safety issue: No ]
  • Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25) [ Time Frame: Baseline to Weeks 3, 6 ] [ Designated as safety issue: No ]
  • Change in Bech Melancholia Score [ Time Frame: Baseline to Weeks 3, 6 ] [ Designated as safety issue: No ]
  • Change in Anxiety/Somatizations Factor Total Score [ Time Frame: Baseline to Weeks 3, 6 ] [ Designated as safety issue: No ]
  • Change in Retardation Factor Scores [ Time Frame: Baseline to Weeks 3, 6 ] [ Designated as safety issue: No ]
  • Change in Sleep Disturbance Factor Score [ Time Frame: Baseline to Weeks 3, 6 ] [ Designated as safety issue: No ]
  • Change in Hamilton Anxiety Rating (HAM-A) [ Time Frame: Baseline to Weeks 3, 6 ] [ Designated as safety issue: No ]
  • Change in Total Score of Young Mania Rating Scale (YMRS) [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • Change in Global Clinical Severity of Symptoms (CGI-S) [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • Change in Global Clinical Improvement of Symptoms (CGI -I) [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
  • Change in Global Assessment of Functioning (GAF) [ Time Frame: Baseline to week 6 (Endpoint) ] [ Designated as safety issue: No ]
  • Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score [ Time Frame: Baseline to week 6 (endpoint) ] [ Designated as safety issue: No ]
  • Change in Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline to week 6 (endpoint) ] [ Designated as safety issue: No ]
  • Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject [ Time Frame: Baseline to week 6 (endpoint) ] [ Designated as safety issue: No ]
  • Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating [ Time Frame: Baseline to week 6 (endpoint) ] [ Designated as safety issue: No ]
  • Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer [ Time Frame: Baseline to week 6 (endpoint) ] [ Designated as safety issue: No ]
  • Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint [ Time Frame: Baseline to Week 6 (endpoint) ] [ Designated as safety issue: No ]

Enrollment: 392
Study Start Date: February 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ziprasidone 20 and 60mg
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)
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).
Placebo Comparator: Placebo Drug: Placebo
Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282464

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Dothan, Alabama, United States, 36303
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 77205
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92804
Pfizer Investigational Site
Cerritos, California, United States, 90703
Pfizer Investigational Site
Chula Vista, California, United States, 91910
Pfizer Investigational Site
Escondido, California, United States, 92025
Pfizer Investigational Site
Los Angeles, California, United States, 90027-5302
Pfizer Investigational Site
Riverside, California, United States, 92506
Pfizer Investigational Site
San Diego, California, United States, 92126
Pfizer Investigational Site
Santa Ana, California, United States, 92705
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80220
United States, Connecticut
Pfizer Investigational Site
Darien, Connecticut, United States, 06820
United States, Florida
Pfizer Investigational Site
Boca Raton, Florida, United States, 33432
Pfizer Investigational Site
Bradenton, Florida, United States, 34208
Pfizer Investigational Site
Jacksonville, Florida, United States, 32256-2006
Pfizer Investigational Site
Melbourne, Florida, United States, 32901
Pfizer Investigational Site
Orange City, Florida, United States, 32763
Pfizer Investigational Site
Tampa, Florida, United States, 33613
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
Pfizer Investigational Site
Marietta, Georgia, United States, 30060
United States, Idaho
Pfizer Investigational Site
Eagle, Idaho, United States, 83616
United States, Illinois
Pfizer Investigational Site
Granite City, Illinois, United States, 62040-4749
United States, Indiana
Pfizer Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Maryland
Pfizer Investigational Site
Glen Burnie, Maryland, United States, 21061
Pfizer Investigational Site
Towson, Maryland, United States, 21204
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63118
United States, New Jersey
Pfizer Investigational Site
Princeton, New Jersey, United States, 08540
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States, 11223
Pfizer Investigational Site
Brooklyn, New York, United States, 11235
Pfizer Investigational Site
New York, New York, United States, 10003
Pfizer Investigational Site
Olean, New York, United States, 14760
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27704
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
Pfizer Investigational Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19149
Pfizer Investigational Site
Scranton, Pennsylvania, United States, 18503
United States, Rhode Island
Pfizer Investigational Site
Lincoln, Rhode Island, United States, 02865
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Pfizer Investigational Site
Houston, Texas, United States, 77007
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22903-4895
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00282464     History of Changes
Other Study ID Numbers: A1281139
Study First Received: January 24, 2006
Results First Received: March 3, 2009
Last Updated: June 1, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bipolar I Depression

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 16, 2014