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 |
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Recruitment Status :
Completed
First Posted : April 18, 2016
Last Update Posted : March 24, 2021
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Treatment Resistant Major Depressive Disorder | Drug: AXS-05 Drug: Bupropion | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 312 participants |
| 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 |
| Study Start Date : | March 2016 |
| Actual Primary Completion Date : | March 20, 2020 |
| Actual Study Completion Date : | March 20, 2020 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: AXS-05 |
Drug: AXS-05
AXS-05 taken daily for 6 weeks. |
| Active Comparator: Bupropion |
Drug: Bupropion
Buproprion taken daily for 6 weeks. |
- 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) ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741791
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| Responsible Party: | Axsome Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT02741791 |
| Other Study ID Numbers: |
AXS-05-301 |
| First Posted: | April 18, 2016 Key Record Dates |
| Last Update Posted: | March 24, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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AXS-05 Major Depressive Disorder Treatment Resistant Depression TRD MDD |
Axsome NMDA receptor Refractory depression Resistant depression Depression |
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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 |