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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141271
First received: August 30, 2005
Last updated: April 3, 2009
Last verified: April 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: Geodon (Ziprasidone)
Drug: Placebo
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, Randomized, Double-Blind, Multicenter, Fixed-Flexible Dose, Placebo-Controlled Study Evaluating the Efficacy and Safety 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 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score [ Time Frame: Baseline to 6 weeks ] [ 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 6 weeks ] [ Designated as safety issue: No ]
  • Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change in Hamilton Depression (HAM-D 17) Total Score [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change in Hamilton Anxiety Rating (HAM-A) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change in Total Score of Young Mania Rating Scale (YMRS) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change in Global Clinical Improvement of Symptoms (CGI -I) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change in Total Score in Hamilton Depression (HAM-D 25) [ Time Frame: Baseline to 6 Weeks ] [ Designated as safety issue: No ]
  • Response as Measured by CGI-I Score Less Than or Equal to 2 [ Time Frame: Week 1 through Week 6 (endpoint) ] [ Designated as safety issue: No ]
  • Change in Sheehan Disability Scale (SDS) Total Score at Endpoint [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
  • Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint [ Time Frame: Baseline to 6 Weeks ] [ Designated as safety issue: No ]
  • Change in Bech Melancholia Score [ Time Frame: Baseline to 6 Weeks ] [ Designated as safety issue: No ]
  • Change in Anxiety/Somatizations Factor Total Score [ Time Frame: Baseline to 6 Weeks ] [ Designated as safety issue: No ]
  • Change in Retardation Factor Scores [ Time Frame: Baseline to 6 Weeks ] [ Designated as safety issue: No ]
  • Change in Sleep Disturbance Factor Score [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change in Verbal Memory Trial Performance Total Score at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint [ Time Frame: Baseline to Week 6 LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint [ Time Frame: Baseline to Week 6 LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Digit Sequencing Task at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Token Motor Task at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Verbal Fluency in Naming Categories at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Verbal Fluency Controlled Word Association at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Symbol Coding at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Tower of London Test at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint [ Time Frame: Baseline to Week 6 LOCF ] [ Designated as safety issue: No ]
  • Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint [ Time Frame: Baseline to Week 6 LOCF ] [ Designated as safety issue: No ]

Enrollment: 536
Study Start Date: July 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 20-40mg BID arm Drug: 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
Active Comparator: 60-80mg bid arm 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
Placebo Comparator: Placebo Drug: Placebo
Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial

  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 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.
  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: NCT00141271

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
United States, California
Pfizer Investigational Site
Dana Point, California, United States, 92629
Pfizer Investigational Site
La Mesa, California, United States, 91942
Pfizer Investigational Site
Laguna Hills, California, United States, 92653
Pfizer Investigational Site
Oceanside, California, United States, 92056
Pfizer Investigational Site
Orange, California, United States, 92868
Pfizer Investigational Site
San Diego, California, United States, 92120
Pfizer Investigational Site
San Diego, California, United States, 92108
Pfizer Investigational Site
Santa Ana, California, United States, 92705
Pfizer Investigational Site
Torrance, California, United States, 90505
United States, Florida
Pfizer Investigational Site
Ft, Lauderdale, Florida, United States, 33319
Pfizer Investigational Site
Ft. Lauderdale, Florida, United States, 33319
Pfizer Investigational Site
Gainesville, Florida, United States, 32607
Pfizer Investigational Site
Hialeah, Florida, United States, 33016
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
North Miami, Florida, United States, 33161
Pfizer Investigational Site
Orlando, Florida, United States, 32806
Pfizer Investigational Site
Winter Park, Florida, United States, 32789
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
United States, Illinois
Pfizer Investigational Site
Maywood, Illinois, United States, 60153
Pfizer Investigational Site
Naperville, Illinois, United States, 60563
Pfizer Investigational Site
Schaumburg, Illinois, United States, 60194
United States, Indiana
Pfizer Investigational Site
Greenwood, Indiana, United States, 46143
Pfizer Investigational Site
Lafayette, Indiana, United States, 47905
United States, Kansas
Pfizer Investigational Site
Prarie Village, Kansas, United States, 66206
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70114
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71105
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01605
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55454
United States, Mississippi
Pfizer Investigational Site
Flowood, Mississippi, United States, 39232
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63144
Pfizer Investigational Site
St. Louis, Missouri, United States, 63128
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Pfizer Investigational Site
Clementon, New Jersey, United States, 08021
Pfizer Investigational Site
Toms River, New Jersey, United States, 08755
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
Staten Island, New York, United States, 10305
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267-0001
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site
Cleveland, Ohio, United States, 44113
Pfizer Investigational Site
Mayfield Village, Ohio, United States, 44143
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73118
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19149
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19131
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
Pfizer Investigational Site
Columbia, South Carolina, United States, 29201
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203-1515
United States, Texas
Pfizer Investigational Site
Bellaire, Texas, United States, 77401
Pfizer Investigational Site
Dallas, Texas, United States, 75234
Pfizer Investigational Site
Dallas, Texas, United States, 75216
Pfizer Investigational Site
DeSoto, Texas, United States, 75115
Pfizer Investigational Site
Galveston, Texas, United States, 77555-0188
Pfizer Investigational Site
Houston, Texas, United States, 77555
Pfizer Investigational Site
Irving, Texas, United States, 75062
Pfizer Investigational Site
Plano, Texas, United States, 75093
Pfizer Investigational Site
Richardson, Texas, United States, 75080
Pfizer Investigational Site
San Antonio, Texas, United States, 78284-7792
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
Wichita Falls, Texas, United States, 76309
United States, Virginia
Pfizer Investigational Site
Arlington, Virginia, United States, 22201
Pfizer Investigational Site
Falls Church, Virginia, United States, 22041
Pfizer Investigational Site
Richmond, Virginia, United States, 23230
Pfizer Investigational Site
Richmond, Virginia, United States, 23229
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23452
United States, Washington
Pfizer Investigational Site
Kirkland, Washington, United States, 98033
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53227
Pfizer Investigational Site
West Allis, Wisconsin, United States, 53227
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: NCT00141271     History of Changes
Other Study ID Numbers: A1281136
Study First Received: August 30, 2005
Results First Received: February 24, 2009
Last Updated: April 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bipolar I Disorder

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

ClinicalTrials.gov processed this record on October 23, 2014