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

History of Changes

Results First Received: March 3, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Bipolar Disorder
Interventions:	Drug: Placebo Drug: Geodon (Ziprasidone)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7 day washout: psychotropic drugs and lithium. 4 week washout: monoamine oxidase inhibitors. Depot neuroleptic DC'd 6 months before study entry.11 subjects assigned to but not treated with drug: 9 lost to follow up, 1 no longer willing to participate, 1 DC'd due to protocol violation

Reporting Groups

	Description
Ziprasidone 20-80mg Bid	For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (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).
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Participant Flow: Overall Study

	Ziprasidone 20-80mg Bid	Placebo
STARTED	185	196
COMPLETED	112	134
NOT COMPLETED	73	62
Adverse Event	26	20
Lack of Efficacy	8	8
Lost to Follow-up	10	10
Withdrawal by Subject	24	10
laboratory abnormality	1	2
Protocol Violation	0	7
Patient moved	1	0
patient non-compliant	3	0
patient no show	0	1
patient incarcerated	0	1
family crisis	0	1
dispensed wrong kit	0	1
dropped due to missed visits	0	1

Baseline Characteristics

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Reporting Groups

	Description
Ziprasidone 20-80mg Bid	For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (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).
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Total	Total of all reporting groups

Baseline Measures

	Ziprasidone 20-80mg Bid	Placebo	Total
Number of Participants [units: participants]	185	196	381
Age [units: years] Mean ± Standard Deviation	40.4 ± 12.5	40.0 ± 11.7	40.2 ± 12.1
Gender [units: participants]
Female	108	111	219
Male	77	85	162

Outcome Measures

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1. Primary:

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

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2. Secondary:

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 ]

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3. Secondary:

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 ]

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4. Secondary:

Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12 [ Time Frame: Week 1 to Week 6 ]

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5. Secondary:

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 ]

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6. Secondary:

Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score [ Time Frame: Baseline to Weeks 3, 6 ]

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7. Secondary:

Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25) [ Time Frame: Baseline to Weeks 3, 6 ]

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8. Secondary:

Change in Bech Melancholia Score [ Time Frame: Baseline to Weeks 3, 6 ]

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9. Secondary:

Change in Anxiety/Somatizations Factor Total Score [ Time Frame: Baseline to Weeks 3, 6 ]

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10. Secondary:

Change in Retardation Factor Scores [ Time Frame: Baseline to Weeks 3, 6 ]

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11. Secondary:

Change in Sleep Disturbance Factor Score [ Time Frame: Baseline to Weeks 3, 6 ]

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12. Secondary:

Change in Hamilton Anxiety Rating (HAM-A) [ Time Frame: Baseline to Weeks 3, 6 ]

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13. Secondary:

Change in Total Score of Young Mania Rating Scale (YMRS) [ Time Frame: Baseline to week 6 ]

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14. Secondary:

Change in Global Clinical Severity of Symptoms (CGI-S) [ Time Frame: Baseline to week 6 ]

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15. Secondary:

Change in Global Clinical Improvement of Symptoms (CGI -I) [ Time Frame: Baseline to Week 6 ]

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16. Secondary:

Change in Global Assessment of Functioning (GAF) [ Time Frame: Baseline to week 6 (Endpoint) ]

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17. Secondary:

Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score [ Time Frame: Baseline to week 6 (endpoint) ]

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18. Secondary:

Change in Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline to week 6 (endpoint) ]

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19. Secondary:

Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject [ Time Frame: Baseline to week 6 (endpoint) ]

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20. Secondary:

Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating [ Time Frame: Baseline to week 6 (endpoint) ]

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21. Secondary:

Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer [ Time Frame: Baseline to week 6 (endpoint) ]

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22. Secondary:

Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint [ Time Frame: Baseline to Week 6 (endpoint) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

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

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