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. 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. |
Baseline to 6 weeks |
|
| 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 |
Baseline to 6 weeks |
|
| 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. |
Baseline to 6 weeks |
|
| 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 |
Baseline, 6 Weeks LOCF |
|
| 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) |
Baseline to 6 weeks |
|
| 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. |
Baseline to 6 weeks |
|
| 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. |
Baseline to 6 weeks |
|
| 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. |
Baseline to 6 weeks |
|
| 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. |
Baseline to 6 weeks |
|
| 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 |
Baseline to 6 weeks |
|
| 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 |
Baseline to 6 weeks |
|
| 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. |
Baseline to 6 Weeks |
|
| 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 |
Week 1 through Week 6 (endpoint) |
|
| 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. |
Baseline to Week 6 |
|
| 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 |
Baseline to 6 Weeks |
|
| 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. |
Baseline to 6 Weeks |
|
| 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. |
Baseline to 6 Weeks |
|
| 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. |
Baseline to 6 Weeks |
|
| 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. |
Baseline to 6 weeks |
|
| 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. |
Baseline to 6 Weeks LOCF |
|
| 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. |
Baseline to 6 Weeks LOCF |
|
| 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. |
Baseline to 6 Weeks LOCF |
|
| 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 |
Baseline to 6 Weeks LOCF |
|
| 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 |
Baseline to 6 Weeks LOCF |
|
| 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 |
Baseline to Week 6 LOCF |
|
| 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 |
Baseline to Week 6 LOCF |
|
| 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 |
Baseline to 6 Weeks LOCF |
|
| 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 |
Baseline to 6 Weeks LOCF |
|
| 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. |
Baseline to 6 Weeks LOCF |
|
| 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 |
Baseline to 6 Weeks LOCF |
|
| 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. |
Baseline to 6 Weeks LOCF |
|
| 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 |
Baseline to 6 Weeks LOCF |
|
| 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. |
Baseline to 6 Weeks LOCF |
|
| 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. |
Baseline to 6 Weeks LOCF |
|
| 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. |
Baseline to 6 Weeks LOCF |
|
| 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 |
Baseline to 6 Weeks LOCF |
|
| 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 |
Baseline to Week 6 LOCF |
|
| 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 |
Baseline to Week 6 LOCF |
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