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

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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
We found this trial at
4
sites
Axsome Study Site
Jacksonville, Florida 32256
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Jacksonville, FL
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Axsome study site
Bellevue, Washington 98007
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Bellevue, WA
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Axsome Study Site
Beverly Hills, California 90210
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Beverly Hills, CA
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Axsome Study Site
Orlando, Florida 32801
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Orlando, FL
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