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.
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.