A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder (STRIDE-1)
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|ClinicalTrials.gov Identifier: NCT02741791|
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : September 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Major Depressive Disorder||Drug: AXS-05 Drug: Bupropion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||March 2019|
AXS-05 taken daily for 6 weeks.
|Active Comparator: Bupropion||
Buproprion taken daily for 6 weeks.
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score [ Time Frame: MADRS change from Baseline to End of Study (6 weeks) ]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.
- Clinical Global Impressions-Severity (CGI-S) [ Time Frame: Baseline to End of Study (6 weeks) ]
- Hamilton Depression Rating Scale - 17 items (HAMD-17) [ Time Frame: Baseline to End of Study (6 weeks) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741791
|Contact: Kellie A. Kennon, BSN||Study Directorfirstname.lastname@example.org|
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