Assessing Symptomatic Clinical Episodes in Depression
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/13/2018 |
| Start Date: | May 30, 2018 |
| End Date: | January 2019 |
A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder
Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind,
active-controlled study in patients diagnosed with major depressive disorder (MDD)
experiencing an acute episode.
active-controlled study in patients diagnosed with major depressive disorder (MDD)
experiencing an acute episode.
Inclusion Criteria:
- Currently meets DSM-5 criteria for MDD
- Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
- Agree to use adequate method of contraception for the duration of the study
- Additional criteria may apply
Exclusion Criteria:
- Suicide risk
- History of treatment resistance in current depressive episode
- History of electroconvulsive therapy, 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
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