Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6. |
Baseline to Week 6 |
|
| Secondary |
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score |
Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF) |
Baseline to Week 6 |
|
| Secondary |
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score |
Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 & 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF. |
Baseline to Week 3, Week 6 |
|
| Secondary |
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12 |
Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF. |
Week 1 to Week 6 |
|
| Secondary |
Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7 |
Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF. |
Week 3, Week 6 |
|
| Secondary |
Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score |
Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 & 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF |
Baseline to Weeks 3, 6 |
|
| Secondary |
Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25) |
Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 & 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF. |
Baseline to Weeks 3, 6 |
|
| Secondary |
Change in Bech Melancholia Score |
Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF. |
Baseline to Weeks 3, 6 |
|
| Secondary |
Change in Anxiety/Somatizations Factor Total Score |
Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF. |
Baseline to Weeks 3, 6 |
|
| Secondary |
Change in Retardation Factor Scores |
Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF. |
Baseline to Weeks 3, 6 |
|
| Secondary |
Change in Sleep Disturbance Factor Score |
Change is observed value at each visit minus baseline value. Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 12. |
Baseline to Weeks 3, 6 |
|
| Secondary |
Change in Hamilton Anxiety Rating (HAM-A) |
Change is observed value at each visit minus baseline value. HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe). Total possible score is 0 - 56. |
Baseline to Weeks 3, 6 |
|
| Secondary |
Change in Total Score of Young Mania Rating Scale (YMRS) |
Change is observed value at each visit minus baseline value. YMRS: 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. Overall is average response Week 1 - 6. |
Baseline to week 6 |
|
| Secondary |
Change in Global Clinical Severity of Symptoms (CGI-S) |
Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill |
Baseline to week 6 |
|
| Secondary |
Change in Global Clinical Improvement of Symptoms (CGI -I) |
Change is observed value at each visit minus baseline value. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range:0=not assessed, 1=very much improved, 7=very much worse |
Baseline to Week 6 |
|
| Secondary |
Change in Global Assessment of Functioning (GAF) |
Change is observed value at each visit minus baseline value. GAF is an instrument used to assess global psychological, social, & occupational functioning. Scale range: 100 = normal and 0 = greatest abnormality. |
Baseline to week 6 (Endpoint) |
|
| Secondary |
Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score |
Change is observed value at each visit minus baseline value. Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life. Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank. Total possible score 15 - 80. |
Baseline to week 6 (endpoint) |
|
| Secondary |
Change in Sheehan Disability Scale (SDS) Total Score |
Change is observed value at each visit minus baseline value. SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities. Scale range: 0-10 with 0=no disruption,10=extreme disruption. Total possible score is 0 - 30. |
Baseline to week 6 (endpoint) |
|
| Secondary |
Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject |
Change is observed value at each visit minus baseline value. BPCoRs: Subject interview with 20-items measuring cognitive deficits & degree of affect on functioning. Scale range:0 to 4, higher numbers, greater impairment. Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF) |
Baseline to week 6 (endpoint) |
|
| Secondary |
Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating |
Change is observed value at each visit minus baseline value. Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits & degree of affect on functioning. Scale: 0 to 4, higher numbers = greater impairment. Total possible score is 0 - 80. Endpoint is LOCF. |
Baseline to week 6 (endpoint) |
|
| Secondary |
Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer |
Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80. |
Baseline to week 6 (endpoint) |
|
| Secondary |
Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint |
Change is observed value at each visit minus baseline value. Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning. Scale 0 to 4, higher numbers reflecting greater impairment. Total possible score is 0 - 80. Endpoint is last observation carried forward. |
Baseline to Week 6 (endpoint) |
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