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

previstos

Centros

24

Fin del objetivo primario

sep 2014

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

Todos los de AVTX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01941043), actualizada en dic 2017.