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

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ClinicalTrials.gov Identifier: NCT00282464
Recruitment Status : Completed
First Posted : January 26, 2006
Results First Posted : June 2, 2009
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Placebo Drug: Geodon (Ziprasidone) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline to Week 6 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12 [ Time Frame: Week 1 to Week 6 ]
  4. 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 ]
  5. Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score [ Time Frame: Baseline to Weeks 3, 6 ]
  6. Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25) [ Time Frame: Baseline to Weeks 3, 6 ]
  7. Change in Bech Melancholia Score [ Time Frame: Baseline to Weeks 3, 6 ]
  8. Change in Anxiety/Somatizations Factor Total Score [ Time Frame: Baseline to Weeks 3, 6 ]
  9. Change in Retardation Factor Scores [ Time Frame: Baseline to Weeks 3, 6 ]
  10. Change in Sleep Disturbance Factor Score [ Time Frame: Baseline to Weeks 3, 6 ]
  11. Change in Hamilton Anxiety Rating (HAM-A) [ Time Frame: Baseline to Weeks 3, 6 ]
  12. Change in Total Score of Young Mania Rating Scale (YMRS) [ Time Frame: Baseline to week 6 ]
  13. Change in Global Clinical Severity of Symptoms (CGI-S) [ Time Frame: Baseline to week 6 ]
  14. Change in Global Clinical Improvement of Symptoms (CGI -I) [ Time Frame: Baseline to Week 6 ]
  15. Change in Global Assessment of Functioning (GAF) [ Time Frame: Baseline to week 6 (Endpoint) ]
  16. Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score [ Time Frame: Baseline to week 6 (endpoint) ]
  17. Change in Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline to week 6 (endpoint) ]
  18. Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject [ Time Frame: Baseline to week 6 (endpoint) ]
  19. Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating [ Time Frame: Baseline to week 6 (endpoint) ]
  20. Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer [ Time Frame: Baseline to week 6 (endpoint) ]
  21. Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint [ Time Frame: Baseline to Week 6 (endpoint) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282464


  Show 43 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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
First Posted: January 26, 2006    Key Record Dates
Results First Posted: June 2, 2009
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by Pfizer:
Bipolar I Depression

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents