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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Axsome Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02741791
First received: April 5, 2016
Last updated: December 1, 2016
Last verified: December 2016
  Purpose

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 Intervention Phase
Treatment Resistant Major Depressive Disorder
Drug: AXS-05
Drug: Bupropion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Axsome Therapeutics, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 350
Study Start Date: March 2016
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AXS-05 Drug: AXS-05
AXS-05 taken daily for 6 weeks.
Active Comparator: Bupropion Drug: Bupropion
Buproprion taken daily for 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02741791

Contacts
Contact: Giovanna Forero, MA Study Director stride-1@axsome.com

  Show 43 Study Locations
Sponsors and Collaborators
Axsome Therapeutics, Inc.
  More Information

Additional Information:
Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02741791     History of Changes
Other Study ID Numbers: AXS-05-301
Study First Received: April 5, 2016
Last Updated: December 1, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: via publication

Keywords provided by Axsome Therapeutics, Inc.:
AXS-05
Major Depressive Disorder
Treatment Resistant Depression
TRD
MDD
Axsome
NMDA receptor
Refractory depression
Resistant depression
Depression

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 24, 2017