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

Treatment Resistant Major Depressive Disorder Clinical Trial

— STRIDE-1  

Official title:

STRIDE-1: A Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of AXS-05 Administered Orally to Subjects With Treatment Resistant Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741791
• Other study ID #: AXS-05-301
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: March 20, 2020

Study information

• Verified date: March 2021
• Source: Axsome Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).

This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD.

Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

• Currently meets DSM-V criteria for MDD

• History of inadequate response to 1 or 2 adequate antidepressant treatments

• Body mass index (BMI) between 18 and 40 kg/m2, inclusive

• Agree to use adequate method of contraception for the duration of the study

• Additional criteria may apply

Key Exclusion Criteria:

• Suicide risk

• Treatment with any investigational drug within 6 months

• History of electroconvulsive therapy (ECT), 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Treatment Resistant Major Depressive Disorder

Intervention

Drug:
• AXS-05
AXS-05 taken daily for 6 weeks.
• Bupropion
Buproprion taken daily for 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Global Impressions-Severity (CGI-S)		Baseline to End of Study (6 weeks)
Secondary	Hamilton Depression Rating Scale - 17 items (HAMD-17)		Baseline to End of Study (6 weeks)

External Links

•   www.TRDstudy.com