A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder (STRIDE-1)
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.
|Treatment Resistant Major Depressive Disorder||Drug: AXS-05 Drug: Bupropion||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|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|
- 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) ]
|Study Start Date:||March 2016|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
AXS-05 taken daily for 6 weeks.
|Active Comparator: Bupropion||
Buproprion taken daily for 6 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02741791
|Contact: Giovanna Forero, MA||Study Directorfirstname.lastname@example.org|
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