MDD Study Overview

Phase 3 Excessive Sleepiness in MDD patients clinical study

Study Title:

A twelve week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the efficacy and safety of Investigational Product in the treatment of excessive sleepiness (ES) in subjects with Major Depressive Disorder.

Study Duration:

A total of 4.5 months for the randomized double-blind trial. This includes up to 28 days for Screening, 1 day for Baseline assessments, 12 weeks for the double-blind Treatment Phase, and 2 weeks for Follow-up. Subjects will then have the option to enroll in a long-term safety extension trial.

Study Design:

This study is a 12-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study evaluating the safety and efficacy of 2 doses of Investigational Product versus placebo in the treatment of ES in subjects with a lifetime diagnosis of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
This study includes a total of 7 clinical visits: at Screening, Baseline, and Weeks 1, 4, 8, and 12, as well as a safety follow-up. Phone contact is made weekly in-between clinic visits.

Inclusion Criteria:

    1. Males and females between 18 and 75 years of age, inclusive.
    2. Lifetime diagnosis of DSM-5 defined MDD as assessed by the MINI.
    3. Acute major depressive episode within the past 5 years.
    4. MADRS score < 15.
    5. Baseline ESS score ≥10.
    6. Stable dose of selective serotonin reuptake inhibitor (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRI) for at least 6 weeks prior to dosing. Adjunctive anti-depressant drugs in addition to SSRI or SNRI are allowed, as long as the dose has been stable for 6 weeks.
    7. Usual nightly total sleep time > 6 hours.
    8. Usual bedtime prior to 1 AM.
    9. Body mass index from 18 to <45 kg/m2.

Exclusion Criteria:

    1. Occupation requiring nighttime or variable shift work.
    2. Moderate to severe obstructive sleep apnea (OSA) defined by an AHI>5 based on home-based apnea testing. Subjects with a historical diagnosis of OSA who are using an approved treatment for OSA with AHI<5 based on home-based apnea testing may be included.
    3. Diagnosis of another sleep disorder including: circadian rhythm sleep disorders, narcolepsy, restless leg syndrome, REM behavior disorder determined by a previous sleep-lab diagnosis or through the sleep disorders interview.
    4. History or current panic disorder, posttraumatic stress disorder, bipolar disorder, bipolar related disorders, active psychotic symptoms, schizophrenia, schizophrenia spectrum disorders, or eating disorders according to DSM-5 criteria.