A Six-week Flexible Dose Study Evaluating the Efficacy an... | NCT00282464

Label	Type	Description	Intervention Names
Ziprasidone 20 and 60mg	Active Comparator	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)
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.	Placebo

Measure	Description	Time Frame
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.	Baseline to Week 6

Measure	Description	Time Frame
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score	Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF)

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Dothan	Alabama	36303	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
23609405	Derived	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.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	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).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score

Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF)

Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases

Not all subjects responded at each week.

Endpoint is ITT population Last Observation Carried Forward (LOCF)

Posted

Number

participants

Baseline to Week 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants	OG000180 OG001190

Title

Denominators

Categories

Week 1: Yes

Title	Measurements
	OG00040 OG00124

Week 1: No

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Week 1	Cochran-Mantel-Haenszel	CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups	0.0056	For all secondary efficacy analyses, no multiple comparison adjustment were made													Superiority or Other (legacy)

Secondary

Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score

Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 & 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF.

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Not all subjects responded at each week.

Endpoint is ITT population Last Observation Carried Forward (LOCF)

Posted

Number

Participants

Baseline to Week 3, Week 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12

Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF.

Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.

Not all subjects responded at each week.

Endpoint is ITT population Last Observation Carried Forward (LOCF)

Posted

Number

Participants

Week 1 to Week 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7

Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF.

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Not all subjects responded at each week.

Endpoint is ITT population Last Observation Carried Forward (LOCF)

Posted

Number

Participants

Week 3, Week 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Primary

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.

Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.

Overall is Average of Weeks 1 - 6.

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to Week 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants	OG000

Secondary

Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score

Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 & 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF

Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to Weeks 3, 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)

Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 & 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF.

Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to Weeks 3, 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Change in Bech Melancholia Score

Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF.

Weeks 3, 6 are Intent to Treat(ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to Weeks 3, 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants	OG000

Secondary

Change in Anxiety/Somatizations Factor Total Score

Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF.

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to Weeks 3, 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Change in Retardation Factor Scores

Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF.

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to Weeks 3, 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants	OG000

Secondary

Change in Sleep Disturbance Factor Score

Change is observed value at each visit minus baseline value. Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 12.

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF)

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to Weeks 3, 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Change in Hamilton Anxiety Rating (HAM-A)

Change is observed value at each visit minus baseline value. HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe). Total possible score is 0 - 56.

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to Weeks 3, 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Change in Total Score of Young Mania Rating Scale (YMRS)

Change is observed value at each visit minus baseline value. YMRS: 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. Overall is average response Week 1 - 6.

Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.

Overall is Average of Weeks 1 - 6.

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to week 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants	OG000

Secondary

Change in Global Clinical Severity of Symptoms (CGI-S)

Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill

Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.

Overall is Average of Weeks 1 - 6.

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to week 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants	OG000

Secondary

Change in Global Clinical Improvement of Symptoms (CGI -I)

Change is observed value at each visit minus baseline value. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range:0=not assessed, 1=very much improved, 7=very much worse

Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.

Overall is Average of Weeks 1 - 6.

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to Week 6

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants	OG000

Secondary

Change in Global Assessment of Functioning (GAF)

Change is observed value at each visit minus baseline value. GAF is an instrument used to assess global psychological, social, & occupational functioning. Scale range: 100 = normal and 0 = greatest abnormality.

Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 154, 169; N = 180, 190

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to week 6 (Endpoint)

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants	OG000

Secondary

Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score

Change is observed value at each visit minus baseline value. Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life. Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank. Total possible score 15 - 80.

Change from baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 153, 168; N = 180, 190

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to week 6 (endpoint)

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Change in Sheehan Disability Scale (SDS) Total Score

Change is observed value at each visit minus baseline value. SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities. Scale range: 0-10 with 0=no disruption,10=extreme disruption. Total possible score is 0 - 30.

Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 149, 162; N = 180, 190

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to week 6 (endpoint)

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject

Change is observed value at each visit minus baseline value. BPCoRs: Subject interview with 20-items measuring cognitive deficits & degree of affect on functioning. Scale range:0 to 4, higher numbers, greater impairment. Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF)

Baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 141, 164; N = 180, 190

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to week 6 (endpoint)

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating

Change is observed value at each visit minus baseline value. Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits & degree of affect on functioning. Scale: 0 to 4, higher numbers = greater impairment. Total possible score is 0 - 80. Endpoint is LOCF.

Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 97, 104; N = 180, 190

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to week 6 (endpoint)

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

Secondary

Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer

Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80.

Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 137, 158; N = 180, 190

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to week 6 (endpoint)

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants	OG000

Secondary

Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint

Change is observed value at each visit minus baseline value. Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning. Scale 0 to 4, higher numbers reflecting greater impairment. Total possible score is 0 - 80. Endpoint is last observation carried forward.

Endpoint is Intent to Treat (ITT) Last Observation Carried Forward (LOCF). n = 140, 162; N = 180, 190

Posted

Least Squares Mean

Standard Error

score on scale

Baseline to Week 6 (endpoint)

ID	Title	Description
OG000	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).
OG001	Placebo

Units	Counts
Participants

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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).			3		93
EG001	Placebo				4		73

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Skin laceration	Injury, poisoning and procedural complications	MedDRA (v11.1)	Systematic Assessment	EG0000 affected185 at risk EG0011 affected196 at risk
Bipolar disorder	Psychiatric disorders		Systematic Assessment	EG0000 affected185 at risk EG0011 affected196 at risk
Psychotic disorder	Psychiatric disorders		Systematic Assessment	EG0000 affected185 at risk EG0011 affected196 at risk
Suicidal ideation	Psychiatric disorders		Systematic Assessment	EG0002 affected185 at risk EG0011 affected196 at risk
Suicide attempt	Psychiatric disorders		Systematic Assessment	EG0001 affected185 at risk EG0010 affected196 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (v11.1)	Systematic Assessment	EG0008 affected185 at risk EG00115 affected196 at risk
Nausea	Gastrointestinal disorders		Systematic Assessment	EG00011 affected185 at risk EG00121 affected196 at risk
Fatigue	General disorders		Systematic Assessment	EG00013 affected185 at risk EG0018 affected196 at risk
Dizziness	Nervous system disorders		Systematic Assessment	EG00012 affected185 at risk EG00110 affected196 at risk
Headache	Nervous system disorders		Systematic Assessment	EG00021 affected185 at risk EG00121 affected196 at risk
Sedation	Nervous system disorders		Systematic Assessment	EG00022 affected185 at risk EG0016 affected196 at risk
Somnolence	Nervous system disorders		Systematic Assessment	EG00025 affected185 at risk EG0015 affected196 at risk
Depression	Psychiatric disorders		Systematic Assessment	EG0006 affected185 at risk EG00113 affected196 at risk
Insomnia	Psychiatric disorders		Systematic Assessment	EG0009 affected185 at risk EG00110 affected196 at risk

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

ID	Title	Description
BG000	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).
BG001	Placebo
BG002	Total	Total of all reporting groups