Conditions: Treatment Resistant Depression
Keywords: Depression Treatment Resistant Depression Antidepressant Major Depression MDD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8
Healthy volunteers: no

Brief summary:
This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of oral CERC-501 for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Detailed description:
This study will involve 10 visits to the clinical site over approximately 1.5 months. There will be a screening visit (7-28 days may pass between the screening visit and the first treatment visit), a baseline/treatment visit (first day of study drug treatment), followed by 5 consecutive days of treatment visits. Follow-up visits will occur 6, 13, and 20 days after first receiving study drug.

Arms:
arm 1: Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2) arm 2: Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2) arm 3: Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2) arm 4: Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2) arm 5: Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)

Interventions: intervention 1: CERC-501 intervention 2: Placebo
Intervention descriptions: intervention 1: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).

High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).

For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.

For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days. intervention 2: For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days).

For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.

For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.

Protocol document: