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

January 24, 2006
June 1, 2009
February 2006
March 2008   (final data collection date for primary outcome measure)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
Compare the efficacy of ziprasidone to placebo over 6-weeks in outpatients with Bipolar Disorder Type I, depressed who have a HAM-D-17 score > 20 and a YMRS score < 12. Primary efficacy measure will be the change from baseline in the MADRS total score.
Complete list of historical versions of study NCT00282464 on ClinicalTrials.gov Archive Site
  • 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 ]
1.Efficacy in depressive symptoms using the HAM-D-17 and HAM-D-25 2.Improvement in anxiety symptoms using the HAM-A 3.Evaluate the incidence of manic symptoms and/or switch using the YMRS 4.Global clinical severity of symptoms using the CGI-Severity
Not Provided
Not Provided
 
A Six-Week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
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

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: Placebo
    Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.
  • 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).
  • 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).
    Intervention: Drug: Geodon (Ziprasidone)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
392
March 2008
March 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 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00282464
A1281139
Yes
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

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