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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 : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE April 5, 2016
First Posted Date  ICMJE April 18, 2016
Last Update Posted Date November 14, 2018
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02741791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Treatment Resistant Major Depressive Disorder
Intervention  ICMJE
  • Drug: AXS-05
    AXS-05 taken daily for 6 weeks.
  • Drug: Bupropion
    Buproprion taken daily for 6 weeks.
Study Arms  ICMJE
  • Experimental: AXS-05
    Intervention: Drug: AXS-05
  • Active Comparator: Bupropion
    Intervention: Drug: Bupropion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2016)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cheryl Askew Study Director stride-1@axsome.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02741791
Other Study ID Numbers  ICMJE AXS-05-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: via publication
Responsible Party Axsome Therapeutics, Inc.
Study Sponsor  ICMJE Axsome Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Axsome Therapeutics, Inc.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP