Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02459236 | A Study of Intermittent Doses of CERC-301 in MDD | PHASE2 | COMPLETED | 115 | — | — | Jun 1, 2015 | Dec 1, 2016 | Sep 28, 2017 | 13 | United States |
| NCT01941043 | A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of CERC-301 in the Adjunctive Treatment of Subjects With Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment | PHASE2 | COMPLETED | 1,357 | — | — | Nov 1, 2013 | Oct 1, 2014 | Dec 21, 2017 | 24 | United States |
To evaluate the antidepressant effect of CERC-301 (12 or 20 mg) compared to placebo averaged between 2 and 4 days post-treatment with study drug assessed by the 6-item unidimensional subset (Bech-6) of the 17-item Hamilton Depression Rating Scale (HDRS-17)
The overall between-treatment difference will be computed as the weighted average of the differences (drug vs. placebo)
| Arm | Type | Description |
|---|---|---|
| CERC-301 12mg | EXPERIMENTAL | The study includes two dose administrations 7 days apart (Day 0 and Day 7) followed by 14 days of observation for a total of 21 days. |
| CERC-301 20mg | EXPERIMENTAL | The study includes two dose administrations 7 days apart (Day 0 and Day 7) followed by 14 days of observation for a total of 21 days. |
| Placebo | PLACEBO_COMPARATOR | The study includes two dose administrations 7 days apart (Day 0 and Day 7) followed by 14 days of observation for a total of 21 days. |
| CERC-301, Treatment Sequence 1 | EXPERIMENTAL | Treatment Sequence 1 - 7 days on placebo and 28 days on study drug (either 12mg or 8mg) |
| CERC-301, Treatment Sequence 2 | EXPERIMENTAL | Treatment Sequence 2 - Placebo for 7 days and study drug for 28 days (8 mgs) |
| Placebo, Treatment Sequence 3 | PLACEBO_COMPARATOR | Treatment Sequence 3 - Placebo for 35 Day treatment period |
| Name | Type | Description |
|---|---|---|
| CERC-301 | DRUG | CERC-301, a highly selective, orally bioavailable, NMDA receptor subunit 2B (NR2B), also referred to as Glutamate NMDA receptor subunit epsilon-2 (GluN2B) antagonist |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Diagnosis of MDD recurrent without psychotic features according to DSM-IV-TR criteria with diagnosis confirmed using the Structured Clinical Interview for DSM-IV Axis I Disorders Clinical Trials Version (SCID-CT). 2. Lifetime history of ≥2 major depressive episodes, for which...