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

August 30, 2005
April 3, 2009
July 2005
February 2008   (final data collection date for primary outcome measure)
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
The primary objective of this study will be to compare the efficacy of ziprasidone to placebo over a 6-week course of treatment in outpatients with a diagnosis of Bipolar Disorder Type I, depressed, with or without rapid cycling, who have a HAM-D-17 scor
Complete list of historical versions of study NCT00141271 on ClinicalTrials.gov Archive Site
  • 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 ]
The main secondary objectives of this study will be:1.To evaluate efficacy in depressive symptoms using the HAM-D-17 and the HAM-D-252.To evaluate improvement in anxiety symptoms using the HAM-A3.To evaluate the incidence of manic symptoms and/or switch
Not Provided
Not Provided
 
A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Bipolar Disorder
  • 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
  • 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
  • Drug: Placebo
    Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial
  • Active Comparator: 20-40mg BID arm
    Intervention: Drug: Geodon (Ziprasidone)
  • Active Comparator: 60-80mg bid arm
    Intervention: Drug: Geodon (Ziprasidone)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
536
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00141271
A1281136
Yes
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP