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.
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.
Brief Title
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
Categories
Completion Date
Completion Date Type
Actual
Conditions
Treatment Resistant Major Depressive Disorder
Eligibility 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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
AXS-05
Major Depressive Disorder
Treatment Resistant Depression
TRD
MDD
Axsome
NMDA receptor
Refractory depression
Resistant depression
Depression
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT02741791
Org Class
Industry
Org Full Name
Axsome Therapeutics, Inc.
Org Study Id
AXS-05-301
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Outcome Time Frame
MADRS change from Baseline to End of Study (6 weeks)
Secondary Outcomes
Outcome Time Frame
Baseline to End of Study (6 weeks)
Outcome Measure
Clinical Global Impressions-Severity (CGI-S)
Outcome Time Frame
Baseline to End of Study (6 weeks)
Outcome Measure
Hamilton Depression Rating Scale - 17 items (HAMD-17)
See Also Links
Url
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Alpert
Investigator Email
jalpert@montefiore.org
Investigator Phone