Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.

Time frame: Baseline, Week 8 or Early termination

Population: Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.

QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3. The total score ranges from 0 to 27, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.

Time frame: Baseline, Week 8 or Early termination

Population: Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.

HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.

Time frame: Baseline, Week 8 or Early termination

Population: Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.

CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.

Time frame: Baseline, Week 8 or Early termination

Population: Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.

MADRS is a scale used in subjects with major depressive disorder to measure the overall severity of depressive symptoms. It is a 10 item, clinician-rated scale that assesses treatment-sensitive change by evaluating ten areas of depressive symptomatology: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. The items are rated on a 7 point Likert scale (0 - 6) with anchors at 2 point intervals. The total score ranges from 0 to 60, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.

Time frame: Baseline, Week 8 or Early termination

Population: Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.

CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.

Time frame: Baseline, Week 8 or Early termination

Population: Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.