Trials Sponsors Conditions Drugs Pricing

Conditions

Treatment Resistant Major Depressive Disorder

Keywords

AXS-05Major Depressive DisorderTreatment Resistant DepressionTRDMDDAxsomeNMDA receptorRefractory depressionResistant depressionDepression

Outcome Measures

Primary Outcomes (1)

Montgomery-Åsberg Depression Rating Scale (MADRS) total score
The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
MADRS change from Baseline to End of Study (6 weeks)

Secondary Outcomes (2)

Clinical Global Impressions-Severity (CGI-S)
Baseline to End of Study (6 weeks)
Hamilton Depression Rating Scale - 17 items (HAMD-17)

Study Arms (2)

AXS-05

EXPERIMENTAL

Drug: AXS-05

Bupropion

ACTIVE COMPARATOR

Drug: Bupropion

Interventions

AXS-05Drug

AXS-05 taken daily for 6 weeks.

AXS-05

BupropionDrug

Buproprion taken daily for 6 weeks.

Bupropion

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Currently meets DSM-V criteria for MDD
History of inadequate response to 1 or 2 adequate antidepressant treatments

Sponsors & Collaborators

Axsome Therapeutics, Inc.
Industrylead

Study Sites (74)

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Anaheim, California, United States

Beverly Hills, California, United States

Garden Grove, California, United States

Oakland, California, United States

Oceanside, California, United States

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive Disorder, Treatment-ResistantDepression

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Enrollment

312 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 18, 2016

Study Start

March 2016

Date type not reported

This date has not been verified as actual or estimated.

A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

AXS-05

Bupropion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (74)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

AXS-05

Bupropion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (74)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations