Conditions: Major Depressive Disorder
Keywords: Adjunctive Depression Major Depressive Disorder (MDD)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 231
Healthy volunteers: no

Brief summary:
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.

Detailed description:

Arms:
arm 1: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo arm 2: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose arm 3: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose

Interventions: intervention 1: Antidepressant + placebo intervention 2: Antidepressant + cariprazine (0.1-0.3 mg/day) intervention 3: Antidepressant + cariprazine (1-2 mg/d)
Intervention descriptions: intervention 1: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period. intervention 2: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period. intervention 3: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

Protocol document: