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CERC-301 · 2 trials · 1 indication
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...
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CERC-301 is an investigational small molecule being developed for the adjunctive treatment of Major Depressive Disorder (MDD). It has been studied in patients with severe depression and recent active suicidal ideation despite antidepressant treatment, as well as in a separate study of intermittent doses in MDD.
CERC-301 is being developed by Avalo Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AVTX. The company has conducted Phase 2 clinical trials of CERC-301 in Major Depressive Disorder.
CERC-301 is in Phase 2 clinical development. Two Phase 2 trials have been completed, both in Major Depressive Disorder. The drug is investigational and has not been approved by the FDA, as it remains in clinical development.
CERC-301 has completed two Phase 2 clinical trials. NCT01941043 was a randomized, double-blind, placebo-controlled study in 1357 patients with severe depression and recent active suicidal ideation despite antidepressant treatment. NCT02459236 studied intermittent doses of CERC-301 in 115 patients with Major Depressive Disorder. Both trials were conducted in the United States.
CERC-301 is the investigational name used by Avalo Therapeutics for this small molecule compound. No alternative names have been reported for this drug in the available clinical trial information.