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REL-1017

Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD

Ensayo de RELMADA THERAPEUTICS, INC. en Depressive Disorder, Major · Depressive Disorder, Treatment-Resistant (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

62

previstos

Centros

10

Fin del objetivo primario

jul 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en may 2018.

Qué mide

Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability] (del registro, en inglés) (21 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication. This population will provide the opportunity to compare the safety and efficacy effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the effects of an antidepressant alone. This study includes in-patient and out-patient periods.

Más ensayos de RLMD

Todos los de RLMD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03051256), actualizada en oct 2023.