Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

Sponsor

Axsome Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04634669

Collaborator

(none)

186

Enrollment

Locations

Arm

17.3

Actual Duration (Months)

9.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with treatment resistant depression (TRD).

Condition or Disease	Intervention/Treatment	Phase
Treatment Resistant Depression Major Depressive Disorder	Drug: AXS-05 (dextromethorphan-bupropion)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

186 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Treatment Resistant Depression

Actual Study Start Date :

Sep 23, 2020

Actual Primary Completion Date :

Mar 4, 2022

Actual Study Completion Date :

Mar 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AXS-05 (dextromethorphan-bupropion)	Drug: AXS-05 (dextromethorphan-bupropion) - AXS-05 tablet, taken daily (up to 15 months)

Arm

Intervention/Treatment

Experimental: AXS-05 (dextromethorphan-bupropion)

Drug: AXS-05 (dextromethorphan-bupropion)

- AXS-05 tablet, taken daily (up to 15 months)

Outcome Measures

Primary Outcome Measures

Incidence of treatment-emergent AEs (TEAEs) following dosing with AXS-05 [Up to 15 months]

Other Outcome Measures

Montgomery-Åsberg Depression Rating Scale (MADRS) [Up to 15 months]
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Continued depression despite treatment with antidepressants in the current depressive episode
Agree to use adequate method of contraception for the duration of the study
Additional criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Site	Little Rock	Arkansas	United States	72209
2	Clinical Research Site	Redlands	California	United States	92374
3	Clinical Research Site	Sherman Oaks	California	United States	91403
4	Clinical Research Site	Upland	California	United States	91786
5	Clinical Research Site	Miami	Florida	United States	33122
6	Clinical Research Site	North Miami	Florida	United States	33161
7	Clinical Research Site	Orlando	Florida	United States	32081
8	Clinical Research Site	Chicago	Illinois	United States	60634
9	Clinical Research Site	Boston	Massachusetts	United States	02131
10	Clinical Research Site	Berlin	New Jersey	United States	08009
11	Clinical Research Site	Rochester	New York	United States	14618
12	Clinical Research Site	Staten Island	New York	United States	10312
13	Clinical Research Site	Hickory	North Carolina	United States	28601
14	Clinical Research Site	Raleigh	North Carolina	United States	27609
15	Clinical Research Site	Cincinnati	Ohio	United States	45215
16	Clinical Research Site	Middleburg Heights	Ohio	United States	44130
17	Clinical Research Site	Media	Pennsylvania	United States	19063
18	Clinical Research Site	Dallas	Texas	United States	75243
19	Clinical Research Site	Friendswood	Texas	United States	77546
20	Clinical Research Site	Everett	Washington	United States	98201