Loading clinical trials...

Assessing Symptomatic Clinical Episodes in Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Assessing Symptomatic Clinical Episodes in Depression

A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder

NCT03595579•Axsome Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

Detailed Description

This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Currently meets DSM-5 criteria for MDD
•Body mass index (BMI) between 18 and 40 kg/m\^2, inclusive
•Agree to use adequate method of contraception for the duration of the study
•Additional criteria may apply

Exclusion Criteria

•Suicide risk
•History of treatment resistance in current depressive episode
•History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
•Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
•Additional criteria may apply

Locations (4)

Clinical Research Site

Beverly Hills, California, United States

Clinical Research Site

Jacksonville, Florida, United States

Clinical Research Site

Orlando, Florida, United States

Clinical Research Site

Bellevue, Washington, United States

Key Dates

Start Date

May 30, 2018

Primary Completion Date

January 7, 2019

Completion Date

January 7, 2019

Last Updated

September 24, 2021

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

AXS-05

DRUG

Bupropion

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

View study

RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Assessing Symptomatic Clinical Episodes in Depression

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use