Calendario›AVTX›CERC-301
CERC-301
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
Ensayo de Avalo Therapeutics, Inc. en Trastorno depresivo mayor.
Más ensayos de: Trastorno depresivo mayor.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 1.357
- Centros
- 24
- Fin del objetivo primario
- sep 2014
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en nov 2013.
Qué mide
HDRS-17 tras 7 dias de administracion del farmaco del estudio (Screening & Days 0, 4, 7, 11, 14, 21,28, & 35) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe current study will evaluate the antidepressant effect of CERC-301 during 28 days of treatment in subjects with MDD who are currently experiencing a severe depressive episode despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine reuptake inhibitors (SSRI or SNRI). The study population will be enriched for subjects that would benefit most from rapid onset, those with recent active suicidal ideation, but not a risk to themselves or others and are deemed appropriate for an out-patient study with careful safety surveillance. This will allow the study to focus on the antidepressant effects of CERC-301 but also explore effects on suicidal ideation. To explore rapid onset, the primary endpoint will be at 7 days, but effects over the 28 days of treatment will be examined as a secondary endpoint.
Más ensayos de AVTX
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| AVTX-009 Regimen 1 · LOTUS | Fase 2 | Completado | feb 2026 (real) |
| AVTX-002 | Fase 2 | Completado | may 2023 (real) |
| CERC-006 | Fase 1 | Retirado antes de empezar | jun 2022 (prevista, ya pasada: sin actualizar en el registro) |
| AEVI-007 | Fase 1 | Completado | mar 2022 (real) |
| MDGN-002 | Fase 1 | Interrumpido | sep 2021 (real) |
| CERC-301 | Fase 2 | Completado | sep 2016 (real) |
Todos los de AVTX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01941043), actualizada en dic 2017.