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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
56 centers in the US

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7-day washout:psychotropic drugs & lithium. 4-week washout: monoamine oxidase inhibitors, fluoxetine alone or in combination with olanzapine. Depot neuroleptic Discontinued (DC'd) 6 mo prior to entry. 536 subjects enrolled: 504 assigned to drug; 32 not assigned:18 lost to follow up, 5 DC'd study, 9 didn't take/receive study drug for other reasons.

Reporting Groups

	Description
120-160mg Ziprasidone	Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
40-80 mg Ziprasidone	Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
Placebo	Subjects were assigned to placebo

Participant Flow:   Overall Study

	120-160mg Ziprasidone	40-80 mg Ziprasidone	Placebo
STARTED	171	165	168
COMPLETED	91	102	111
NOT COMPLETED	80	63	57
Adverse Event	31	19	17
Laboratory Abnormality	2	1	1
Lack of Efficacy	7	7	3
Lost to Follow-up	15	15	21
Withdrawal by Subject	14	9	10
Unknown	11	12	5

Reporting Groups

	Description
120-160mg Ziprasidone	Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
40-80 mg Ziprasidone	Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
Placebo	Subjects were assigned to placebo
Total	Total of all reporting groups

Baseline Measures

	120-160mg Ziprasidone	40-80 mg Ziprasidone	Placebo	Total
Number of Participants   [units: participants]	171	165	168	504
Age   [units: years] Mean ± Standard Deviation	40.4  ± 12.9	40.0  ± 11.4	39.3  ± 11.2	39.9  ± 11.8
Gender   [units: participants]
Female	91	101	92	284
Male	80	64	76	220

1.  Primary:

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

2.  Secondary:

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 ]

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 6 weeks ]

4.  Secondary:

Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline, 6 Weeks LOCF ]

5.  Secondary:

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

6.  Secondary:

Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7   [ Time Frame: Baseline to 6 weeks ]

7.  Secondary:

Change in Hamilton Depression (HAM-D 17) Total Score   [ Time Frame: Baseline to 6 weeks ]

8.  Secondary:

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

9.  Secondary:

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

10.  Secondary:

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

11.  Secondary:

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

12.  Secondary:

Change in Total Score in Hamilton Depression (HAM-D 25)   [ Time Frame: Baseline to 6 Weeks ]

13.  Secondary:

Response as Measured by CGI-I Score Less Than or Equal to 2   [ Time Frame: Week 1 through Week 6 (endpoint) ]

14.  Secondary:

Change in Sheehan Disability Scale (SDS) Total Score at Endpoint   [ Time Frame: Baseline to Week 6 ]

15.  Secondary:

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

16.  Secondary:

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

17.  Secondary:

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

18.  Secondary:

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

19.  Secondary:

Change in Sleep Disturbance Factor Score   [ Time Frame: Baseline to 6 weeks ]

20.  Secondary:

Change in Verbal Memory Trial Performance Total Score at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

21.  Secondary:

Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

22.  Secondary:

Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

23.  Secondary:

Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

24.  Secondary:

Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

25.  Secondary:

Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint   [ Time Frame: Baseline to Week 6 LOCF ]

26.  Secondary:

Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint   [ Time Frame: Baseline to Week 6 LOCF ]

27.  Secondary:

Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

28.  Secondary:

Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

29.  Secondary:

Change in Digit Sequencing Task at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

30.  Secondary:

Change in Token Motor Task at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

31.  Secondary:

Change in Verbal Fluency in Naming Categories at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

32.  Secondary:

Change in Verbal Fluency Controlled Word Association at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

33.  Secondary:

Change in Symbol Coding at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

34.  Secondary:

Change in Tower of London Test at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

35.  Secondary:

Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

36.  Secondary:

Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

37.  Secondary:

Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint   [ Time Frame: Baseline to Week 6 LOCF ]

38.  Secondary:

Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint   [ Time Frame: Baseline to Week 6 LOCF ]