Bipolar Disorder
Conditions
Keywords
Bipolar I Disorder
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.
Interventions
Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial
DRUGPlacebo
Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Diagnostic and Statistical Manual (of Mental Disorders) - Fourth Edition - Text Revision (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 not otherwise specified (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Baseline to 6 weeks | Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Baseline to 6 weeks | Participants with greater than or equal to 50 percent decrease from baseline in HAMD-17 total score responded yes; others responded no. Endpoint is LOCF endpoint among Week 1 - 6; Total score is first 17 items of HAM-D 25: measures range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52. |
| Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF) | Baseline, 6 Weeks LOCF | Change is observed value at endpoint minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 - 6; GAF is used to assess global psychological, social, & occupational functioning; 100=normal and 0=greatest abnormality |
| Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Baseline to 6 weeks | Response was Yes if MADRS Total Score was less than, equal to 12, if not, response was no. Endpoint is LOCF endpoint among Week 1 through 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6(most abnormal) |
| Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Baseline to 6 weeks | Response was yes when HAM-D 17 total score was less than or equal to 7 , if not, response was no. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25,which measures the range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52. |
| Change in Hamilton Depression (HAM-D 17) Total Score | Baseline to 6 weeks | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25, which measures the range of depressive symptoms patient currently experiencing; scale 0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score 0 - 52. |
| Change in Hamilton Anxiety Rating (HAM-A) | Baseline to 6 weeks | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. HAM-A is a 14-item scale: rates intensity of psychic anxiety and somatic anxiety on a 5-point severity scale (range: 0=not present to 4=very severe). Total possible score is 0 - 56. |
| Change in Total Score of Young Mania Rating Scale (YMRS) | Baseline to 6 weeks | Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. YMRS: 11 item instrument with scale 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. |
| Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Baseline to 6 weeks | Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-S measures severity of patient's mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill |
| Change in Global Clinical Improvement of Symptoms (CGI -I) | Baseline to 6 weeks | Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. 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 |
| Change in Total Score in Hamilton Depression (HAM-D 25) | Baseline to 6 Weeks | Change: observed value at each visit minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 through Week 6. HAM-D 25: measures the range of depressive symptoms experienced. 25 Items with Scale range:0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.Total possible score is 0 - 72. |
| Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 1 through Week 6 (endpoint) | Response each week was yes if CGI-I score less than or equal to 2 (much or very much improved), if not, response was no; Endpoint is LOCF endpoint among Week 1 through Week 6. CGI-I is a Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse |
| Change in Sheehan Disability Scale (SDS) Total Score at Endpoint | Baseline to Week 6 | Observed value each visit minus baseline value. Endpoint is LOCF Week 1 through Week 6. SDS: patient rated measure of disability and impairment in 3 items: work/school, social life, family life/home responsibilities:0(no disruption)- 10(extreme disruption). Total possible is 30. |
| Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint | Baseline to 6 Weeks | Change is observed value at each visit minus baseline value. LOCF endpoint among Week 1 through Week 6. Q-LES-Q: 16-item instrument for patients assessment of his/her quality of life; overall level of satisfaction scale 1=very poor to 5=Very good (1 item re medication can be blank). Total possible score 15 - 80 |
| Change in Bech Melancholia Score | Baseline to 6 Weeks | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Bech Melancholia is the sum of Scores on 6 Items pertaining to melancholia within Hamilton Depression Rating Scale (HAM-D). Scale 0 to 4, higher scores reflecting greater severity;Total possible 0 - 24. |
| Change in Anxiety/Somatizations Factor Total Score | Baseline to 6 Weeks | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores on 6 Items measuring anxiety/somatization within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4, higher scores reflecting greater severity. Total possible 0 - 24. |
| Change in Retardation Factor Scores | Baseline to 6 Weeks | Change is observed value at each visit minus baseline value. This instrument = sum of Scores of 4 items on retardation within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 16. |
| Change in Sleep Disturbance Factor Score | Baseline to 6 weeks | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores of 3 items on sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 12. |
| Change in Verbal Memory Trial Performance Total Score at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is part of Brief Assessment of Cognition and measures recall of 15 words repeated 5 times. Range 0-75 words, higher number reflects better recall. |
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Baseline to 6 weeks | Participants with MADRS Total Score greater or equal to 50 percent decrease from baseline responded yes; others responded no. Endpoint is last observation carried forward (LOCF) among Week 1 - Week 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6 (most abnormal). Total possible score is 0 - 60 |
| Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument measures immediate recall of 15 non-emotional words (List 1); higher number of words is better recall. |
| Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is in Brief Assessment of Cognition and measures immediate recall of 15 emotional words (List 2); higher number of words is better recall |
| Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 2); higher number of words is better recall |
| Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint | Baseline to Week 6 LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 emotional words (List 3); higher number of words is better recall |
| Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint | Baseline to Week 6 LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 3); higher number of words is better recall |
| Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 non-emotional words; higher number of words is better recall |
| Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 emotional words; higher number of words is better recall |
| Change in Digit Sequencing Task at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which patient sequences digits from lowest to highest. Range of number of correct responses (0-28); higher numbers show better digit sequencing and greater cognition. |
| Change in Token Motor Task at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which a patient places as many of 100 tokens (2 at a time) into a container as they can within 60 seconds. The higher number of tokens placed = patient is better at motor tasks |
| Change in Verbal Fluency in Naming Categories at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition.Patients are given 60 seconds to name as many words as possible within a given category. The more words named=better cognition. |
| Change in Verbal Fluency Controlled Word Association at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. Patients given 60 seconds to generate as many words as possible that begin with a given letter; better verbal fluency = more words |
| Change in Symbol Coding at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. For 90 seconds, Patient writes numerals 1-9 as matched to symbols. Range 0 to 110 with higher totals = better cognition. |
| Change in Tower of London Test at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint: LOCF endpoint among Week 1 through Week 6. Brief Assessment of Cognition: subjects asked to arrange balls in 2 pictures so they are identical and give the total number of ball movements to reach this arrangment. Range: 0-22; more correct = better cognition. |
| Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition in which the number of correct emotional words in delayed recognition is measured. Range 0-75 with higher numbers showing better cognition. |
| Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition which measures number of correct emotional word's false alarms (during delayed recognition). Higher number = better cognition |
| Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint | Baseline to Week 6 LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of Non-Emotional Words (Delayed Recognition); higher number of words = better cognition |
| Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint | Baseline to Week 6 LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of correct non-eEmotional word's false alarms(at delayed recognition). Higher number of words = greater cognition |
| Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint | Baseline to 6 Weeks LOCF | Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition measuring immediate recall of 15 emotional words; higher number of words is better recall. |
Countries
United States
Participant flow
Recruitment details
56 centers in the US
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 120-160mg Ziprasidone Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day) | 171 |
| 40-80 mg Ziprasidone Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID) | 165 |
| Placebo Subjects were assigned to placebo | 168 |
| Total | 504 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 31 | 19 | 17 |
| Overall Study | Laboratory Abnormality | 2 | 1 | 1 |
| Overall Study | Lack of Efficacy | 7 | 7 | 3 |
| Overall Study | Lost to Follow-up | 15 | 15 | 21 |
| Overall Study | Other | 11 | 12 | 5 |
| Overall Study | Withdrawal by Subject | 14 | 9 | 10 |
Baseline characteristics
| Characteristic | 120-160mg Ziprasidone | 40-80 mg Ziprasidone | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 12.9 | 40.0 years STANDARD_DEVIATION 11.4 | 39.3 years STANDARD_DEVIATION 11.2 | 39.9 years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 91 Participants | 101 Participants | 92 Participants | 284 Participants |
| Sex: Female, Male Male | 80 Participants | 64 Participants | 76 Participants | 220 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 89 / — | 70 / — | 57 / — |
| serious Total, serious adverse events | 7 / — | 3 / — | 6 / — |
Outcome results
Primary
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.
Time frame: Baseline to 6 weeks
Population: Intent to treat (ITT) population observed cases
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Overall (n=166, 158, 162) | -11.40 score on scale | Standard Error 0.73 |
| 120-160mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 6 (n=95, 107, 115) | -13.81 score on scale | Standard Error 1.02 |
| 120-160mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 3 (n=120, 131, 138) | -11.61 score on scale | Standard Error 0.88 |
| 120-160mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 5 (n=99, 115, 123) | -14.25 score on scale | Standard Error 0.94 |
| 120-160mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 1 (n=161, 153, 159) | -6.07 score on scale | Standard Error 0.62 |
| 120-160mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 4 (n=106, 126, 131) | -12.54 score on scale | Standard Error 0.88 |
| 120-160mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 2 (n=135, 142, 146) | -10.12 score on scale | Standard Error 0.79 |
| 40-80 mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 4 (n=106, 126, 131) | -13.87 score on scale | Standard Error 0.91 |
| 40-80 mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 5 (n=99, 115, 123) | -14.53 score on scale | Standard Error 0.9 |
| 40-80 mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 6 (n=95, 107, 115) | -14.77 score on scale | Standard Error 0.97 |
| 40-80 mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 2 (n=135, 142, 146) | -10.20 score on scale | Standard Error 0.82 |
| 40-80 mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Overall (n=166, 158, 162) | -12.33 score on scale | Standard Error 0.74 |
| 40-80 mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 3 (n=120, 131, 138) | -12.93 score on scale | Standard Error 0.85 |
| 40-80 mg Ziprasidone | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 1 (n=161, 153, 159) | -7.66 score on scale | Standard Error 0.73 |
| Placebo | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Overall (n=166, 158, 162) | -10.89 score on scale | Standard Error 0.72 |
| Placebo | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 1 (n=161, 153, 159) | -5.75 score on scale | Standard Error 0.65 |
| Placebo | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 2 (n=135, 142, 146) | -9.47 score on scale | Standard Error 0.77 |
| Placebo | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 3 (n=120, 131, 138) | -11.37 score on scale | Standard Error 0.81 |
| Placebo | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 4 (n=106, 126, 131) | -12.49 score on scale | Standard Error 0.82 |
| Placebo | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 5 (n=99, 115, 123) | -12.99 score on scale | Standard Error 0.97 |
| Placebo | Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 6 (n=95, 107, 115) | -13.25 score on scale | Standard Error 1 |
Comparison: Week 1p-value: 0.6409Mixed Models Analysis
Comparison: Week 1p-value: 0.014Mixed Models Analysis
Comparison: Week 2p-value: 0.484Mixed Models Analysis
Comparison: Week 2p-value: 0.4444Mixed Models Analysis
Comparison: Week 3p-value: 0.8129Mixed Models Analysis
Comparison: Week 3p-value: 0.1105Mixed Models Analysis
Comparison: Week 4p-value: 0.9582Mixed Models Analysis
Comparison: Week 4p-value: 0.1893Mixed Models Analysis
Comparison: Week 5p-value: 0.2924Mixed Models Analysis
Comparison: Week 5p-value: 0.1897Mixed Models Analysis
Comparison: Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups.p-value: 0.6608Mixed Models Analysis
Comparison: Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups.p-value: 0.2148Mixed Models Analysis
Comparison: Overallp-value: 0.529Mixed Models Analysis
Comparison: Overallp-value: 0.0811Mixed Models Analysis
Secondary
Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition in which the number of correct emotional words in delayed recognition is measured. Range 0-75 with higher numbers showing better cognition.
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint | -0.37 Words | Standard Error 0.22 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint | 0.15 Words | Standard Error 0.22 |
| Placebo | Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint | 0.23 Words | Standard Error 0.22 |
Comparison: Endpointp-value: 0.0082ANCOVA
Comparison: Endpointp-value: 0.7037ANCOVA
Secondary
Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition which measures number of correct emotional word's false alarms (during delayed recognition). Higher number = better cognition
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint | 0.09 Number Correct | Standard Error 0.1 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint | 0.01 Number Correct | Standard Error 0.1 |
| Placebo | Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint | -0.03 Number Correct | Standard Error 0.1 |
Comparison: Endpointp-value: 0.2718ANCOVA
Comparison: Endpointp-value: 0.7077ANCOVA
Secondary
Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of Non-Emotional Words (Delayed Recognition); higher number of words = better cognition
Time frame: Baseline to Week 6 LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint | -0.18 Number Correct | Standard Error 0.23 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint | -0.24 Number Correct | Standard Error 0.23 |
| Placebo | Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint | -0.02 Number Correct | Standard Error 0.24 |
Comparison: Endpointp-value: 0.5057ANCOVA
Comparison: Endpointp-value: 0.3654ANCOVA
Secondary
Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of correct non-eEmotional word's false alarms(at delayed recognition). Higher number of words = greater cognition
Time frame: Baseline to Week 6 LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint | 0.06 Number Correct | Standard Error 0.15 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint | 0.19 Number Correct | Standard Error 0.15 |
| Placebo | Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint | 0.14 Number Correct | Standard Error 0.16 |
Comparison: Endpointp-value: 0.6227ANCOVA
Comparison: Endpointp-value: 0.7737ANCOVA
Secondary
Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 emotional words; higher number of words is better recall
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint | -0.06 words | Standard Error 0.2 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint | -0.07 words | Standard Error 0.2 |
| Placebo | Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint | 0.08 words | Standard Error 0.2 |
Comparison: Endpointp-value: 0.4749ANCOVA
Comparison: Endpointp-value: 0.4491ANCOVA
Secondary
Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 non-emotional words; higher number of words is better recall
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint | -0.39 words | Standard Error 0.18 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint | -0.01 words | Standard Error 0.18 |
| Placebo | Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint | -0.32 words | Standard Error 0.19 |
Comparison: Endpointp-value: 0.7019ANCOVA
Comparison: Endpointp-value: 0.102ANCOVA
Secondary
Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition measuring immediate recall of 15 emotional words; higher number of words is better recall.
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint | -0.28 words | Standard Error 0.15 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint | -0.30 words | Standard Error 0.15 |
| Placebo | Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint | -0.06 words | Standard Error 0.16 |
Comparison: Endpointp-value: 0.1836ANCOVA
Comparison: Endpointp-value: 0.1374ANCOVA
Secondary
Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is in Brief Assessment of Cognition and measures immediate recall of 15 emotional words (List 2); higher number of words is better recall
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint | -0.09 words | Standard Error 0.19 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint | -0.05 words | Standard Error 0.19 |
| Placebo | Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint | 0.05 words | Standard Error 0.19 |
Comparison: Endpointp-value: 0.4624ANCOVA
Comparison: Endpointp-value: 0.5971ANCOVA
Secondary
Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 2); higher number of words is better recall
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint | -0.16 words | Standard Error 0.19 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint | 0.07 words | Standard Error 0.19 |
| Placebo | Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint | 0.13 words | Standard Error 0.2 |
Comparison: Endpointp-value: 0.1378ANCOVA
Comparison: Endpointp-value: 0.7665ANCOVA
Secondary
Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 emotional words (List 3); higher number of words is better recall
Time frame: Baseline to Week 6 LOCF
Population: Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint | -0.18 words | Standard Error 0.21 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint | -0.30 words | Standard Error 0.2 |
| Placebo | Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint | -0.03 words | Standard Error 0.21 |
Comparison: Endpointp-value: 0.4767ANCOVA
Comparison: Endpointp-value: 0.2066ANCOVA
Secondary
Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 3); higher number of words is better recall
Time frame: Baseline to Week 6 LOCF
Population: Intent to treat (ITT) population observed cases
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint | -0.52 words | Standard Error 0.19 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint | -0.15 words | Standard Error 0.19 |
| Placebo | Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint | -0.24 words | Standard Error 0.2 |
Comparison: Endpointp-value: 0.1667ANCOVA
Comparison: Endpointp-value: 0.6727ANCOVA
Secondary
Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument measures immediate recall of 15 non-emotional words (List 1); higher number of words is better recall.
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint | -0.02 words | Standard Error 0.15 |
| 40-80 mg Ziprasidone | Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint | 0.14 words | Standard Error 0.15 |
| Placebo | Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint | -0.00 words | Standard Error 0.16 |
Comparison: Endpointp-value: 0.9237ANCOVA
Comparison: Endpointp-value: 0.3786ANCOVA
Secondary
Change in Anxiety/Somatizations Factor Total Score
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores on 6 Items measuring anxiety/somatization within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4, higher scores reflecting greater severity. Total possible 0 - 24.
Time frame: Baseline to 6 Weeks
Population: ITT Population Observed Cases
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Anxiety/Somatizations Factor Total Score | Week 6 (n = 104,117,125) | -3.67 score on scale | Standard Error 0.4 |
| 120-160mg Ziprasidone | Change in Anxiety/Somatizations Factor Total Score | Week 3 (n = 147,149,148) | -2.69 score on scale | Standard Error 0.3 |
| 120-160mg Ziprasidone | Change in Anxiety/Somatizations Factor Total Score | Endpoint (n = 151,150,153) | -3.04 score on scale | Standard Error 0.34 |
| 40-80 mg Ziprasidone | Change in Anxiety/Somatizations Factor Total Score | Week 6 (n = 104,117,125) | -3.88 score on scale | Standard Error 0.38 |
| 40-80 mg Ziprasidone | Change in Anxiety/Somatizations Factor Total Score | Week 3 (n = 147,149,148) | -2.92 score on scale | Standard Error 0.3 |
| 40-80 mg Ziprasidone | Change in Anxiety/Somatizations Factor Total Score | Endpoint (n = 151,150,153) | -3.39 score on scale | Standard Error 0.34 |
| Placebo | Change in Anxiety/Somatizations Factor Total Score | Week 3 (n = 147,149,148) | -2.98 score on scale | Standard Error 0.3 |
| Placebo | Change in Anxiety/Somatizations Factor Total Score | Endpoint (n = 151,150,153) | -3.32 score on scale | Standard Error 0.34 |
| Placebo | Change in Anxiety/Somatizations Factor Total Score | Week 6 (n = 104,117,125) | -3.62 score on scale | Standard Error 0.38 |
Comparison: Week 3p-value: 0.3355ANCOVA
Comparison: Week 3p-value: 0.8447ANCOVA
Comparison: Week 6p-value: 0.8959ANCOVA
Comparison: Week 6p-value: 0.4826ANCOVA
Comparison: Endpointp-value: 0.4178ANCOVA
Comparison: Endpointp-value: 0.8277ANCOVA
Secondary
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-S measures severity of patient's mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill
Time frame: Baseline to 6 weeks
Population: ITT population Observed Cases
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 5 (n=98, 115, 123) | -1.33 score on scale | Standard Error 0.11 |
| 120-160mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 6 (n=94, 107, 115) | -1.38 score on scale | Standard Error 0.12 |
| 120-160mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Overall (n=165, 158, 162) | -1.02 score on scale | Standard Error 0.09 |
| 120-160mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 3 (n=119, 131, 137) | -0.90 score on scale | Standard Error 0.11 |
| 120-160mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 1 (n=161, 152, 158) | -0.05 score on scale | Standard Error 0.08 |
| 120-160mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 4 (n=105, 126, 130) | -1.14 score on scale | Standard Error 0.11 |
| 120-160mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 2 (n=133, 142, 147) | -0.84 score on scale | Standard Error 0.09 |
| 40-80 mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 1 (n=161, 152, 158) | -0.47 score on scale | Standard Error 0.07 |
| 40-80 mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 5 (n=98, 115, 123) | -1.35 score on scale | Standard Error 0.12 |
| 40-80 mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 2 (n=133, 142, 147) | -0.82 score on scale | Standard Error 0.09 |
| 40-80 mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 4 (n=105, 126, 130) | -1.23 score on scale | Standard Error 0.11 |
| 40-80 mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 3 (n=119, 131, 137) | -1.15 score on scale | Standard Error 0.1 |
| 40-80 mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Overall (n=165, 158, 162) | -1.07 score on scale | Standard Error 0.09 |
| 40-80 mg Ziprasidone | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 6 (n=94, 107, 115) | -1.38 score on scale | Standard Error 0.12 |
| Placebo | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Overall (n=165, 158, 162) | -0.97 score on scale | Standard Error 0.08 |
| Placebo | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 6 (n=94, 107, 115) | -1.35 score on scale | Standard Error 0.12 |
| Placebo | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 1 (n=161, 152, 158) | -0.42 score on scale | Standard Error 0.07 |
| Placebo | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 2 (n=133, 142, 147) | -0.75 score on scale | Standard Error 0.09 |
| Placebo | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 3 (n=119, 131, 137) | -0.93 score on scale | Standard Error 0.09 |
| Placebo | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 4 (n=105, 126, 130) | -1.14 score on scale | Standard Error 0.1 |
| Placebo | Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) | Week 5 (n=98, 115, 123) | -1.23 score on scale | Standard Error 0.11 |
Comparison: Week 1p-value: 0.2878Mixed Models Analysis
Comparison: Week 1p-value: 0.4481Mixed Models Analysis
Comparison: Week 2p-value: 0.4099Mixed Models Analysis
Comparison: Week 2p-value: 0.5093Mixed Models Analysis
Comparison: Week 3p-value: 0.8048Mixed Models Analysis
Comparison: Week 3p-value: 0.0552Mixed Models Analysis
Comparison: Week 4p-value: 0.9795Mixed Models Analysis
Comparison: Week 4p-value: 0.5073Mixed Models Analysis
Comparison: Week 5p-value: 0.4882Mixed Models Analysis
Comparison: Week 5p-value: 0.3967Mixed Models Analysis
Comparison: Week 6p-value: 0.8276Mixed Models Analysis
Comparison: Week 6p-value: 0.8502Mixed Models Analysis
Comparison: Overallp-value: 0.6343Mixed Models Analysis
Comparison: Overallp-value: 0.3082Mixed Models Analysis
Secondary
Change in Bech Melancholia Score
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Bech Melancholia is the sum of Scores on 6 Items pertaining to melancholia within Hamilton Depression Rating Scale (HAM-D). Scale 0 to 4, higher scores reflecting greater severity;Total possible 0 - 24.
Time frame: Baseline to 6 Weeks
Population: ITT Population Observed cases
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Bech Melancholia Score | Week 6 (n = 104, 117, 125) | -6.91 score on scale | Standard Error 0.65 |
| 120-160mg Ziprasidone | Change in Bech Melancholia Score | Week 3 (n = 147, 149, 148) | -5.12 score on scale | Standard Error 0.47 |
| 120-160mg Ziprasidone | Change in Bech Melancholia Score | Endpoint (n =151, 150, 153) | -5.85 score on scale | Standard Error 0.54 |
| 40-80 mg Ziprasidone | Change in Bech Melancholia Score | Week 6 (n = 104, 117, 125) | -6.93 score on scale | Standard Error 0.62 |
| 40-80 mg Ziprasidone | Change in Bech Melancholia Score | Week 3 (n = 147, 149, 148) | -5.61 score on scale | Standard Error 0.47 |
| 40-80 mg Ziprasidone | Change in Bech Melancholia Score | Endpoint (n =151, 150, 153) | -6.23 score on scale | Standard Error 0.54 |
| Placebo | Change in Bech Melancholia Score | Week 3 (n = 147, 149, 148) | -5.22 score on scale | Standard Error 0.47 |
| Placebo | Change in Bech Melancholia Score | Endpoint (n =151, 150, 153) | -5.70 score on scale | Standard Error 0.54 |
| Placebo | Change in Bech Melancholia Score | Week 6 (n = 104, 117, 125) | -6.23 score on scale | Standard Error 0.61 |
Comparison: Week 3p-value: 0.8464ANCOVA
Comparison: Week 3p-value: 0.4023ANCOVA
Comparison: Week 6p-value: 0.287ANCOVA
Comparison: Week 6p-value: 0.2537ANCOVA
Comparison: Endpointp-value: 0.7909ANCOVA
Comparison: Endpointp-value: 0.3308ANCOVA
Secondary
Change in Digit Sequencing Task at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which patient sequences digits from lowest to highest. Range of number of correct responses (0-28); higher numbers show better digit sequencing and greater cognition.
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Digit Sequencing Task at Endpoint | 0.76 Number Correct | Standard Error 0.37 |
| 40-80 mg Ziprasidone | Change in Digit Sequencing Task at Endpoint | 0.09 Number Correct | Standard Error 0.37 |
| Placebo | Change in Digit Sequencing Task at Endpoint | 0.46 Number Correct | Standard Error 0.38 |
Comparison: Endpointp-value: 0.4398ANCOVA
Comparison: Endpointp-value: 0.3331ANCOVA
Secondary
Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)
Change is observed value at endpoint minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 - 6; GAF is used to assess global psychological, social, & occupational functioning; 100=normal and 0=greatest abnormality
Time frame: Baseline, 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases, Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF) | 10.11 score on scale | Standard Error 1.38 |
| 40-80 mg Ziprasidone | Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF) | 11.72 score on scale | Standard Error 1.37 |
| Placebo | Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF) | 11.19 score on scale | Standard Error 1.4 |
Comparison: Endpointp-value: 0.4327ANCOVA
Comparison: Endpointp-value: 0.7041ANCOVA
Secondary
Change in Global Clinical Improvement of Symptoms (CGI -I)
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. 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
Time frame: Baseline to 6 weeks
Population: ITT population Observed Cases
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 6 (n=95,107, 115) | 2.49 score on scale | Standard Error 0.13 |
| 120-160mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 4 (n=106,126,130) | 2.54 score on scale | Standard Error 0.11 |
| 120-160mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 3 (n=120,131,137) | 2.90 score on scale | Standard Error 0.13 |
| 120-160mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 1 (n=162, 152, 158) | 3.34 score on scale | Standard Error 0.09 |
| 120-160mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Overall (n=166, 158, 162) | 2.77 score on scale | Standard Error 0.1 |
| 120-160mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 5 (n=99, 115, 123) | 2.47 score on scale | Standard Error 0.12 |
| 120-160mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 2 (n=134, 142, 147) | 2.86 score on scale | Standard Error 0.11 |
| 40-80 mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 3 (n=120,131,137) | 2.62 score on scale | Standard Error 0.11 |
| 40-80 mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 1 (n=162, 152, 158) | 3.17 score on scale | Standard Error 0.09 |
| 40-80 mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 2 (n=134, 142, 147) | 2.82 score on scale | Standard Error 0.1 |
| 40-80 mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 4 (n=106,126,130) | 2.53 score on scale | Standard Error 0.11 |
| 40-80 mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 5 (n=99, 115, 123) | 2.48 score on scale | Standard Error 0.12 |
| 40-80 mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 6 (n=95,107, 115) | 2.43 score on scale | Standard Error 0.13 |
| 40-80 mg Ziprasidone | Change in Global Clinical Improvement of Symptoms (CGI -I) | Overall (n=166, 158, 162) | 2.67 score on scale | Standard Error 0.09 |
| Placebo | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 3 (n=120,131,137) | 2.83 score on scale | Standard Error 0.1 |
| Placebo | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 5 (n=99, 115, 123) | 2.59 score on scale | Standard Error 0.12 |
| Placebo | Change in Global Clinical Improvement of Symptoms (CGI -I) | Overall (n=166, 158, 162) | 2.81 score on scale | Standard Error 0.09 |
| Placebo | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 2 (n=134, 142, 147) | 3.01 score on scale | Standard Error 0.1 |
| Placebo | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 6 (n=95,107, 115) | 2.52 score on scale | Standard Error 0.12 |
| Placebo | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 4 (n=106,126,130) | 2.55 score on scale | Standard Error 0.1 |
| Placebo | Change in Global Clinical Improvement of Symptoms (CGI -I) | Week 1 (n=162, 152, 158) | 3.38 score on scale | Standard Error 0.09 |
Comparison: Week 1p-value: 0.6932Mixed Models Analysis
Comparison: Week 1p-value: 0.0287Mixed Models Analysis
Comparison: Week 2p-value: 0.2128Mixed Models Analysis
Comparison: Week 2p-value: 0.1118Mixed Models Analysis
Comparison: Week 3p-value: 0.6144Mixed Models Analysis
Comparison: Week 3p-value: 0.0899Mixed Models Analysis
Comparison: Week 4p-value: 0.8819Mixed Models Analysis
Comparison: Week 4p-value: 0.8374Mixed Models Analysis
Comparison: Week 5p-value: 0.3925Mixed Models Analysis
Comparison: Week 5p-value: 0.4182Mixed Models Analysis
Comparison: Week 6p-value: 0.8586Mixed Models Analysis
Comparison: Week 6p-value: 0.549Mixed Models Analysis
Comparison: Overallp-value: 0.6292Mixed Models Analysis
Comparison: Overallp-value: 0.1473Mixed Models Analysis
Secondary
Change in Hamilton Anxiety Rating (HAM-A)
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. HAM-A is a 14-item scale: rates intensity of psychic anxiety and somatic anxiety on a 5-point severity scale (range: 0=not present to 4=very severe). Total possible score is 0 - 56.
Time frame: Baseline to 6 weeks
Population: ITT population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Hamilton Anxiety Rating (HAM-A) | Week 6 (n= 104, 117, 124) | -7.63 score on scale | Standard Error 0.94 |
| 120-160mg Ziprasidone | Change in Hamilton Anxiety Rating (HAM-A) | Week 3 (n= 147, 148, 147) | -5.54 score on scale | Standard Error 0.74 |
| 120-160mg Ziprasidone | Change in Hamilton Anxiety Rating (HAM-A) | Endpoint (n= 151, 150, 152) | -6.40 score on scale | Standard Error 0.81 |
| 40-80 mg Ziprasidone | Change in Hamilton Anxiety Rating (HAM-A) | Week 6 (n= 104, 117, 124) | -7.46 score on scale | Standard Error 0.89 |
| 40-80 mg Ziprasidone | Change in Hamilton Anxiety Rating (HAM-A) | Week 3 (n= 147, 148, 147) | -6.46 score on scale | Standard Error 0.74 |
| 40-80 mg Ziprasidone | Change in Hamilton Anxiety Rating (HAM-A) | Endpoint (n= 151, 150, 152) | -6.75 score on scale | Standard Error 0.81 |
| Placebo | Change in Hamilton Anxiety Rating (HAM-A) | Week 3 (n= 147, 148, 147) | -6.79 score on scale | Standard Error 0.74 |
| Placebo | Change in Hamilton Anxiety Rating (HAM-A) | Endpoint (n= 151, 150, 152) | -6.82 score on scale | Standard Error 0.82 |
| Placebo | Change in Hamilton Anxiety Rating (HAM-A) | Week 6 (n= 104, 117, 124) | -6.73 score on scale | Standard Error 0.89 |
Comparison: Week 3p-value: 0.0896ANCOVA
Comparison: Week 3p-value: 0.6534ANCOVA
Comparison: Week 6p-value: 0.327ANCOVA
Comparison: Week 6p-value: 0.4099ANCOVA
Comparison: Endpointp-value: 0.6104ANCOVA
Comparison: Endpointp-value: 0.9359ANCOVA
Secondary
Change in Hamilton Depression (HAM-D 17) Total Score
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25, which measures the range of depressive symptoms patient currently experiencing; scale 0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score 0 - 52.
Time frame: Baseline to 6 weeks
Population: ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Hamilton Depression (HAM-D 17) Total Score | Week 6 (n= 104,117,125) | -12.37 score on scale | Standard Error 1.12 |
| 120-160mg Ziprasidone | Change in Hamilton Depression (HAM-D 17) Total Score | Week 3 (n= 147, 149, 148) | -9.56 score on scale | Standard Error 0.82 |
| 120-160mg Ziprasidone | Change in Hamilton Depression (HAM-D 17) Total Score | Endpoint (n= 151,150,153) | -10.48 score on scale | Standard Error 0.95 |
| 40-80 mg Ziprasidone | Change in Hamilton Depression (HAM-D 17) Total Score | Week 6 (n= 104,117,125) | -12.82 score on scale | Standard Error 1.06 |
| 40-80 mg Ziprasidone | Change in Hamilton Depression (HAM-D 17) Total Score | Week 3 (n= 147, 149, 148) | -10.58 score on scale | Standard Error 0.81 |
| 40-80 mg Ziprasidone | Change in Hamilton Depression (HAM-D 17) Total Score | Endpoint (n= 151,150,153) | -11.48 score on scale | Standard Error 0.95 |
| Placebo | Change in Hamilton Depression (HAM-D 17) Total Score | Week 3 (n= 147, 149, 148) | -10.13 score on scale | Standard Error 0.82 |
| Placebo | Change in Hamilton Depression (HAM-D 17) Total Score | Endpoint (n= 151,150,153) | -10.60 score on scale | Standard Error 0.95 |
| Placebo | Change in Hamilton Depression (HAM-D 17) Total Score | Week 6 (n= 104,117,125) | -11.30 score on scale | Standard Error 1.06 |
Comparison: Week 3p-value: 0.4869ANCOVA
Comparison: Week 3p-value: 0.5813ANCOVA
Comparison: Week 6p-value: 0.3303ANCOVA
Comparison: Week 6p-value: 0.1546ANCOVA
Comparison: Endpointp-value: 0.8982ANCOVA
Comparison: Endpointp-value: 0.3586ANCOVA
Secondary
Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint
Change is observed value at each visit minus baseline value. LOCF endpoint among Week 1 through Week 6. Q-LES-Q: 16-item instrument for patients assessment of his/her quality of life; overall level of satisfaction scale 1=very poor to 5=Very good (1 item re medication can be blank). Total possible score 15 - 80
Time frame: Baseline to 6 Weeks
Population: ITT Population Observed Cases.n= 142, 137, 139; number of subjects who responded to the scale. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint | 0.08 score on scale | Standard Error 0.02 |
| 40-80 mg Ziprasidone | Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint | 0.09 score on scale | Standard Error 0.02 |
| Placebo | Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint | 0.09 score on scale | Standard Error 0.02 |
Comparison: Endpointp-value: 0.5407ANCOVA
Comparison: Endpointp-value: 0.6079ANCOVA
Secondary
Change in Retardation Factor Scores
Change is observed value at each visit minus baseline value. This instrument = sum of Scores of 4 items on retardation within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 16.
Time frame: Baseline to 6 Weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Retardation Factor Scores | Week 6 (n = 104,117,125) | -4.44 score on scale | Standard Error 0.42 |
| 120-160mg Ziprasidone | Change in Retardation Factor Scores | Week 3 (n = 147,149,148) | -3.50 score on scale | Standard Error 0.32 |
| 120-160mg Ziprasidone | Change in Retardation Factor Scores | Endpoint (n = 151,150,153) | -3.89 score on scale | Standard Error 0.35 |
| 40-80 mg Ziprasidone | Change in Retardation Factor Scores | Week 6 (n = 104,117,125) | -4.40 score on scale | Standard Error 0.4 |
| 40-80 mg Ziprasidone | Change in Retardation Factor Scores | Week 3 (n = 147,149,148) | -3.64 score on scale | Standard Error 0.32 |
| 40-80 mg Ziprasidone | Change in Retardation Factor Scores | Endpoint (n = 151,150,153) | -3.99 score on scale | Standard Error 0.35 |
| Placebo | Change in Retardation Factor Scores | Week 3 (n = 147,149,148) | -3.59 score on scale | Standard Error 0.33 |
| Placebo | Change in Retardation Factor Scores | Endpoint (n = 151,150,153) | -3.62 score on scale | Standard Error 0.35 |
| Placebo | Change in Retardation Factor Scores | Week 6 (n = 104,117,125) | -3.79 score on scale | Standard Error 0.4 |
Comparison: Week 3p-value: 0.7758ANCOVA
Comparison: Week 3p-value: 0.8737ANCOVA
Comparison: Week 6p-value: 0.1151ANCOVA
Comparison: Week 6p-value: 0.129ANCOVA
Comparison: Endpointp-value: 0.4432ANCOVA
Comparison: Endpointp-value: 0.2988ANCOVA
Secondary
Change in Sheehan Disability Scale (SDS) Total Score at Endpoint
Observed value each visit minus baseline value. Endpoint is LOCF Week 1 through Week 6. SDS: patient rated measure of disability and impairment in 3 items: work/school, social life, family life/home responsibilities:0(no disruption)- 10(extreme disruption). Total possible is 30.
Time frame: Baseline to Week 6
Population: ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 - 6; n= 128, 126, 128; number of subjects who responded to the scale.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Sheehan Disability Scale (SDS) Total Score at Endpoint | -5.78 score on scale | Standard Error 1.01 |
| 40-80 mg Ziprasidone | Change in Sheehan Disability Scale (SDS) Total Score at Endpoint | -5.43 score on scale | Standard Error 1.02 |
| Placebo | Change in Sheehan Disability Scale (SDS) Total Score at Endpoint | -6.79 score on scale | Standard Error 1.02 |
Comparison: Endpointp-value: 0.3299ANCOVA
Comparison: Endpointp-value: 0.1915ANCOVA
Secondary
Change in Sleep Disturbance Factor Score
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores of 3 items on sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 12.
Time frame: Baseline to 6 weeks
Population: ITT Population Observed cases
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Sleep Disturbance Factor Score | Endpoint (n = 151, 150 153) | -1.90 score on scale | Standard Error 0.24 |
| 120-160mg Ziprasidone | Change in Sleep Disturbance Factor Score | Week 6 (n = 104, 117, 125) | -2.20 score on scale | Standard Error 0.3 |
| 120-160mg Ziprasidone | Change in Sleep Disturbance Factor Score | Week 3 (n = 147, 149, 148) | -1.92 score on scale | Standard Error 0.24 |
| 40-80 mg Ziprasidone | Change in Sleep Disturbance Factor Score | Endpoint (n = 151, 150 153) | -1.98 score on scale | Standard Error 0.24 |
| 40-80 mg Ziprasidone | Change in Sleep Disturbance Factor Score | Week 3 (n = 147, 149, 148) | -2.07 score on scale | Standard Error 0.23 |
| 40-80 mg Ziprasidone | Change in Sleep Disturbance Factor Score | Week 6 (n = 104, 117, 125) | -2.19 score on scale | Standard Error 0.28 |
| Placebo | Change in Sleep Disturbance Factor Score | Week 6 (n = 104, 117, 125) | -2.06 score on scale | Standard Error 0.28 |
| Placebo | Change in Sleep Disturbance Factor Score | Week 3 (n = 147, 149, 148) | -1.96 score on scale | Standard Error 0.24 |
| Placebo | Change in Sleep Disturbance Factor Score | Endpoint (n = 151, 150 153) | -1.96 score on scale | Standard Error 0.24 |
Comparison: Week 3p-value: 0.8598ANCOVA
Comparison: Week 3p-value: 0.6513ANCOVA
Comparison: Week 6p-value: 0.6272ANCOVA
Comparison: Week 6p-value: 0.6467ANCOVA
Comparison: Endpointp-value: 0.8049ANCOVA
Comparison: Endpointp-value: 0.9411ANCOVA
Secondary
Change in Symbol Coding at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. For 90 seconds, Patient writes numerals 1-9 as matched to symbols. Range 0 to 110 with higher totals = better cognition.
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Symbol Coding at Endpoint | 1.34 Total Correct | Standard Error 1.18 |
| 40-80 mg Ziprasidone | Change in Symbol Coding at Endpoint | 1.07 Total Correct | Standard Error 1.16 |
| Placebo | Change in Symbol Coding at Endpoint | 2.66 Total Correct | Standard Error 1.21 |
Comparison: Endpointp-value: 0.2847ANCOVA
Comparison: Endpointp-value: 0.1958ANCOVA
Secondary
Change in Token Motor Task at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which a patient places as many of 100 tokens (2 at a time) into a container as they can within 60 seconds. The higher number of tokens placed = patient is better at motor tasks
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Token Motor Task at Endpoint | 0.28 Number of Tokens | Standard Error 1.54 |
| 40-80 mg Ziprasidone | Change in Token Motor Task at Endpoint | -0.00 Number of Tokens | Standard Error 1.53 |
| Placebo | Change in Token Motor Task at Endpoint | 2.02 Number of Tokens | Standard Error 1.57 |
Comparison: Endpointp-value: 0.2763ANCOVA
Comparison: Endpointp-value: 0.2048ANCOVA
Secondary
Change in Total Score in Hamilton Depression (HAM-D 25)
Change: observed value at each visit minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 through Week 6. HAM-D 25: measures the range of depressive symptoms experienced. 25 Items with Scale range:0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.Total possible score is 0 - 72.
Time frame: Baseline to 6 Weeks
Population: ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Total Score in Hamilton Depression (HAM-D 25) | Week 6 (n= 104, 117, 125) | -14.59 score on scale | Standard Error 1.32 |
| 120-160mg Ziprasidone | Change in Total Score in Hamilton Depression (HAM-D 25) | Week 3 (n= 147, 149, 147) | -11.02 score on scale | Standard Error 0.98 |
| 120-160mg Ziprasidone | Change in Total Score in Hamilton Depression (HAM-D 25) | Endpoint (n= 151, 150, 153) | -12.25 score on scale | Standard Error 1.11 |
| 40-80 mg Ziprasidone | Change in Total Score in Hamilton Depression (HAM-D 25) | Week 6 (n= 104, 117, 125) | -15.08 score on scale | Standard Error 1.25 |
| 40-80 mg Ziprasidone | Change in Total Score in Hamilton Depression (HAM-D 25) | Week 3 (n= 147, 149, 147) | -12.16 score on scale | Standard Error 0.97 |
| 40-80 mg Ziprasidone | Change in Total Score in Hamilton Depression (HAM-D 25) | Endpoint (n= 151, 150, 153) | -13.36 score on scale | Standard Error 1.11 |
| Placebo | Change in Total Score in Hamilton Depression (HAM-D 25) | Week 3 (n= 147, 149, 147) | -12.25 score on scale | Standard Error 0.98 |
| Placebo | Change in Total Score in Hamilton Depression (HAM-D 25) | Endpoint (n= 151, 150, 153) | -12.78 score on scale | Standard Error 1.11 |
| Placebo | Change in Total Score in Hamilton Depression (HAM-D 25) | Week 6 (n= 104, 117, 125) | -13.74 score on scale | Standard Error 1.24 |
Comparison: Week 3p-value: 0.2058ANCOVA
Comparison: Week 3p-value: 0.9254ANCOVA
Comparison: Week 6p-value: 0.5071ANCOVA
Comparison: Week 6p-value: 0.2858ANCOVA
Comparison: Endpointp-value: 0.6298ANCOVA
Comparison: Endpointp-value: 0.6034ANCOVA
Secondary
Change in Total Score of Young Mania Rating Scale (YMRS)
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. YMRS: 11 item instrument with scale 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.
Time frame: Baseline to 6 weeks
Population: ITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 120-160mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 2 (n = 114,124,123) | 0.16 score on scale | Standard Error 0.38 |
| 120-160mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 5 (n = 87, 105, 109) | -0.89 score on scale | Standard Error 0.43 |
| 120-160mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 4 (n = 93, 116, 116) | -0.09 score on scale | Standard Error 0.43 |
| 120-160mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 1 (n = 140,131, 132) | 0.05 score on scale | Standard Error 0.34 |
| 120-160mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Overall (n = 161, 158, 161) | -0.27 score on scale | Standard Error 0.33 |
| 120-160mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 6 (n = 95, 107, 115) | -0.86 score on scale | Standard Error 0.42 |
| 120-160mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 3 (n = 120, 130, 138) | -0.03 score on scale | Standard Error 0.44 |
| 40-80 mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 4 (n = 93, 116, 116) | 0.19 score on scale | Standard Error 0.49 |
| 40-80 mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 1 (n = 140,131, 132) | 0.64 score on scale | Standard Error 0.41 |
| 40-80 mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 2 (n = 114,124,123) | 0.64 score on scale | Standard Error 0.41 |
| 40-80 mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 3 (n = 120, 130, 138) | 0.11 score on scale | Standard Error 0.39 |
| 40-80 mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 5 (n = 87, 105, 109) | -0.82 score on scale | Standard Error 0.43 |
| 40-80 mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 6 (n = 95, 107, 115) | -0.03 score on scale | Standard Error 0.5 |
| 40-80 mg Ziprasidone | Change in Total Score of Young Mania Rating Scale (YMRS) | Overall (n = 161, 158, 161) | 0.12 score on scale | Standard Error 0.36 |
| Placebo | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 5 (n = 87, 105, 109) | -0.28 score on scale | Standard Error 0.45 |
| Placebo | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 2 (n = 114,124,123) | 0.51 score on scale | Standard Error 0.37 |
| Placebo | Change in Total Score of Young Mania Rating Scale (YMRS) | Overall (n = 161, 158, 161) | -0.26 score on scale | Standard Error 0.32 |
| Placebo | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 6 (n = 95, 107, 115) | -1.00 score on scale | Standard Error 0.42 |
| Placebo | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 4 (n = 93, 116, 116) | -0.73 score on scale | Standard Error 0.41 |
| Placebo | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 3 (n = 120, 130, 138) | 0.05 score on scale | Standard Error 0.4 |
| Placebo | Change in Total Score of Young Mania Rating Scale (YMRS) | Week 1 (n = 140,131, 132) | -0.08 score on scale | Standard Error 0.33 |
Comparison: Week 1p-value: 0.6924Mixed Models Analysis
Comparison: Week 1p-value: 0.08Mixed Models Analysis
Comparison: Week 2p-value: 0.4238Mixed Models Analysis
Comparison: Week 2p-value: 0.7714Mixed Models Analysis
Comparison: Week 3p-value: 0.8731Mixed Models Analysis
Comparison: Week 3p-value: 0.8926Mixed Models Analysis
Comparison: Week 4p-value: 0.2072Mixed Models Analysis
Comparison: Week 4p-value: 0.1042Mixed Models Analysis
Comparison: Week 5p-value: 0.2695Mixed Models Analysis
Comparison: Week 5p-value: 0.3245Mixed Models Analysis
Comparison: Week 6p-value: 0.7791Mixed Models Analysis
Comparison: Week 6p-value: 0.0999Mixed Models Analysis
Comparison: Overallp-value: 0.9543Mixed Models Analysis
Comparison: Overallp-value: 0.3153Mixed Models Analysis
Secondary
Change in Tower of London Test at Endpoint
Change is observed value at each visit minus baseline value. Endpoint: LOCF endpoint among Week 1 through Week 6. Brief Assessment of Cognition: subjects asked to arrange balls in 2 pictures so they are identical and give the total number of ball movements to reach this arrangment. Range: 0-22; more correct = better cognition.
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Tower of London Test at Endpoint | 0.31 Number Correct | Standard Error 0.41 |
| 40-80 mg Ziprasidone | Change in Tower of London Test at Endpoint | 0.68 Number Correct | Standard Error 0.41 |
| Placebo | Change in Tower of London Test at Endpoint | 0.91 Number Correct | Standard Error 0.43 |
Comparison: Endpointp-value: 0.1652ANCOVA
Comparison: Endpointp-value: 0.5997ANCOVA
Secondary
Change in Verbal Fluency Controlled Word Association at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. Patients given 60 seconds to generate as many words as possible that begin with a given letter; better verbal fluency = more words
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Verbal Fluency Controlled Word Association at Endpoint | 1.09 Number Correct | Standard Error 0.67 |
| 40-80 mg Ziprasidone | Change in Verbal Fluency Controlled Word Association at Endpoint | -0.15 Number Correct | Standard Error 0.66 |
| Placebo | Change in Verbal Fluency Controlled Word Association at Endpoint | 1.54 Number Correct | Standard Error 0.69 |
Comparison: Endpointp-value: 0.5195ANCOVA
Comparison: Endpointp-value: 0.0153ANCOVA
Secondary
Change in Verbal Fluency in Naming Categories at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition.Patients are given 60 seconds to name as many words as possible within a given category. The more words named=better cognition.
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Verbal Fluency in Naming Categories at Endpoint | 0.19 Number Correct | Standard Error 0.58 |
| 40-80 mg Ziprasidone | Change in Verbal Fluency in Naming Categories at Endpoint | -0.11 Number Correct | Standard Error 0.58 |
| Placebo | Change in Verbal Fluency in Naming Categories at Endpoint | -0.28 Number Correct | Standard Error 0.6 |
Comparison: Endpointp-value: 0.434ANCOVA
Comparison: Endpointp-value: 0.7774ANCOVA
Secondary
Change in Verbal Memory Trial Performance Total Score at Endpoint
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is part of Brief Assessment of Cognition and measures recall of 15 words repeated 5 times. Range 0-75 words, higher number reflects better recall.
Time frame: Baseline to 6 Weeks LOCF
Population: Intent to Treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 120-160mg Ziprasidone | Change in Verbal Memory Trial Performance Total Score at Endpoint | 1.31 words | Standard Error 0.97 |
| 40-80 mg Ziprasidone | Change in Verbal Memory Trial Performance Total Score at Endpoint | 0.85 words | Standard Error 0.96 |
| Placebo | Change in Verbal Memory Trial Performance Total Score at Endpoint | 1.22 words | Standard Error 1 |
Comparison: Endpointp-value: 0.926ANCOVA
Comparison: Endpointp-value: 0.71ANCOVA
Secondary
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
Response was yes when HAM-D 17 total score was less than or equal to 7 , if not, response was no. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25,which measures the range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.
Time frame: Baseline to 6 weeks
Population: ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6~Not all subjects answered each week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 120-160mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 3; Yes | 27 Participants |
| 120-160mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 3; No | 120 Participants |
| 120-160mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 6; Yes | 41 Participants |
| 120-160mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 6; No | 63 Participants |
| 120-160mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Endpoint: Yes | 45 Participants |
| 120-160mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Endpoint: No | 106 Participants |
| 40-80 mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Endpoint: No | 106 Participants |
| 40-80 mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 3; Yes | 30 Participants |
| 40-80 mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 6; No | 74 Participants |
| 40-80 mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Endpoint: Yes | 44 Participants |
| 40-80 mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 3; No | 119 Participants |
| 40-80 mg Ziprasidone | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 6; Yes | 43 Participants |
| Placebo | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 3; No | 113 Participants |
| Placebo | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 6; Yes | 43 Participants |
| Placebo | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Endpoint: No | 106 Participants |
| Placebo | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 6; No | 82 Participants |
| Placebo | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Week 3; Yes | 35 Participants |
| Placebo | Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 | Endpoint: Yes | 47 Participants |
Comparison: Week 3p-value: 0.3888Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.3122Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.3323Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.8781Cochran-Mantel-Haenszel
Comparison: Endpointp-value: 0.9485Cochran-Mantel-Haenszel
Comparison: Endpointp-value: 0.7331Cochran-Mantel-Haenszel
Secondary
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Response was Yes if MADRS Total Score was less than, equal to 12, if not, response was no. Endpoint is LOCF endpoint among Week 1 through 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6(most abnormal)
Time frame: Baseline to 6 weeks
Population: ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6;~Not all subjects answered each week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 6; Yes | 58 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 3; No | 64 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 2; Yes | 48 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 5; No | 34 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 4; Yes | 55 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 1; No | 143 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 5; Yes | 65 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 4; No | 51 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 6; No | 37 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 2; No | 87 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Endpoint; No | 93 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 1; Yes | 18 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 3; Yes | 56 participants |
| 120-160mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Endpoint; Yes | 73 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 6; Yes | 63 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 1; Yes | 27 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 1; No | 126 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 2; Yes | 41 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 2; No | 101 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 3; Yes | 61 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 3; No | 70 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 4; Yes | 65 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 4; No | 61 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 5; Yes | 66 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 5; No | 49 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 6; No | 44 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Endpoint; Yes | 72 participants |
| 40-80 mg Ziprasidone | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Endpoint; No | 86 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Endpoint; Yes | 73 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 5; No | 57 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 3; Yes | 55 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 2; No | 102 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 6; Yes | 61 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 2; Yes | 44 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 1; Yes | 25 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 6; No | 54 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 1; No | 134 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 4; No | 65 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 4; Yes | 66 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Endpoint; No | 89 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 5; Yes | 66 participants |
| Placebo | Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 | Week 3; No | 83 participants |
Comparison: Week 1p-value: 0.2076Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.7449Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.4399Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.7107Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.4765Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.2564Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.8063Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.9855Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.0599Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.7364Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.3048Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.5139Cochran-Mantel-Haenszel
Comparison: Endpointp-value: 0.9356Cochran-Mantel-Haenszel
Comparison: Endpointp-value: 0.9428Cochran-Mantel-Haenszel
Secondary
Response as Measured by CGI-I Score Less Than or Equal to 2
Response each week was yes if CGI-I score less than or equal to 2 (much or very much improved), if not, response was no; Endpoint is LOCF endpoint among Week 1 through Week 6. CGI-I is a Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse
Time frame: Week 1 through Week 6 (endpoint)
Population: ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.~Not all subjects answered each week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 4; Yes | 68 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 2; No | 82 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 1; Yes | 20 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 1; No | 142 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 2; Yes | 52 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 3; Yes | 51 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 3; No | 69 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 4; No | 38 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 5; Yes | 69 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 5; No | 30 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 6; Yes | 60 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 6; No | 35 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Endpoint; Yes | 74 Participants |
| 120-160mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Endpoint; No | 92 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 3; Yes | 71 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 6; No | 31 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 3; No | 60 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 4; Yes | 76 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 4; No | 50 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Endpoint; No | 75 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 5; Yes | 74 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Endpoint; Yes | 83 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 5; No | 41 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 1; Yes | 34 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 6; Yes | 76 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 1; No | 118 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 2; Yes | 54 Participants |
| 40-80 mg Ziprasidone | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 2; No | 88 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 6; Yes | 66 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 3; Yes | 58 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 5; No | 50 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Endpoint; Yes | 77 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 3; No | 79 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 2; No | 97 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 4; Yes | 70 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 6; No | 49 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 1; Yes | 28 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 4; No | 60 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 2; Yes | 50 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Endpoint; No | 85 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 5; Yes | 73 Participants |
| Placebo | Response as Measured by CGI-I Score Less Than or Equal to 2 | Week 1; No | 130 Participants |
Comparison: Week 1p-value: 0.1454Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.2672Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.2614Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.2143Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.6997Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.0128Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.1144Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.1483Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.0674Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.29Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.5482Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.0303Cochran-Mantel-Haenszel
Comparison: Endpointp-value: 0.6143Cochran-Mantel-Haenszel
Comparison: Endpointp-value: 0.3385Cochran-Mantel-Haenszel
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 HAMD-17 total score responded yes; others responded no. Endpoint is LOCF endpoint among Week 1 - 6; Total score is first 17 items of HAM-D 25: measures range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.
Time frame: Baseline to 6 weeks
Population: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6~Not all subjects answered each Week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 3: Yes | 60 participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 3: No | 87 participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 6: Yes | 64 participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 6: No | 40 participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Endpoint: Yes | 74 participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Endpoint: No | 77 participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Endpoint: No | 68 participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 3: Yes | 67 participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 6: No | 44 participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Endpoint: Yes | 82 participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 3: No | 82 participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 6: Yes | 73 participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 3: No | 87 participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 6: Yes | 73 participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Endpoint: No | 72 participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 6: No | 52 participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Week 3: Yes | 61 participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Endpoint: Yes | 81 participants |
Comparison: Week 3p-value: 0.8921Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.435Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.562Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.6959Cochran-Mantel-Haenszel
Comparison: Endpointp-value: 0.7865Cochran-Mantel-Haenszel
Comparison: Endpointp-value: 0.7564Cochran-Mantel-Haenszel
Secondary
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Participants with MADRS Total Score greater or equal to 50 percent decrease from baseline responded yes; others responded no. Endpoint is last observation carried forward (LOCF) among Week 1 - Week 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6 (most abnormal). Total possible score is 0 - 60
Time frame: Baseline to 6 weeks
Population: Intent to treat (ITT) population observed cases.~Not all subjects answered at each Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 4: Yes | 56 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 2: No | 84 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 2 : Yes | 51 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Endpoint: Yes | 76 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 5: Yes | 67 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 1: No | 142 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 6: No | 37 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 5: No | 32 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 3: Yes | 57 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 4: No | 50 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 1: Yes | 19 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 3: No | 63 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 6: Yes | 58 Participants |
| 120-160mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Endpoint: No | 90 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 2 : Yes | 50 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 6: Yes | 69 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 2: No | 92 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 3: Yes | 67 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 3: No | 64 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 4: Yes | 70 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 4: No | 56 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 5: Yes | 74 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 5: No | 41 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 6: No | 38 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Endpoint: Yes | 83 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Endpoint: No | 75 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 1: Yes | 32 Participants |
| 40-80 mg Ziprasidone | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 1: No | 121 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 4: No | 63 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 2 : Yes | 51 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Endpoint: Yes | 80 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 3: No | 78 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 1: No | 133 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Endpoint: No | 82 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 3: Yes | 60 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 4: Yes | 68 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 1: Yes | 26 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 5: No | 52 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 6: Yes | 67 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 5: Yes | 71 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 2: No | 95 Participants |
| Placebo | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score | Week 6: No | 48 Participants |
Comparison: Week 1p-value: 0.2287Cochran-Mantel-Haenszel
Comparison: Week1p-value: 0.4734Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.7401Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.7904Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.5274Cochran-Mantel-Haenszel
Comparison: Week 3p-value: 0.1059Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.8871Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.6939Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.1044Cochran-Mantel-Haenszel
Comparison: Week 5p-value: 0.3132Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.6978Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.3228Cochran-Mantel-Haenszel
Comparison: Endpointp-value: 0.6432Cochran-Mantel-Haenszel
Comparison: Endpointp-value: 0.5989Cochran-Mantel-Haenszel