A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/16/2018 |
| Start Date: | March 2016 |
| End Date: | March 2019 |
| Contact: | Cheryl Askew |
| Email: | stride-1@axsome.com |
| Phone: | Study Director |
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
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 (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.
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
We found this trial at
75
sites
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