Summary:
The purpose of this research study is to determine the effect of SAGE-217, an investigational medication, on overall insomnia symptoms in subjects with Major Depressive Disorder (MDD) and Insomnia. This study is comprised of 7 office visits and 4 overnight stays in the sleep clinic over approximately 8 ½ weeks.
The first visit consists of a physical with our physician, blood draw, ECG, urine specimen collection and urine drug screen. All Study related procedures, physical exams, and study medication are at no cost and qualified participants will receive reimbursement for travel and related expenses for completed study visits.
Inclusion Criteria:
- De novo subjects must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ADHD (including predominantly inattentive presentation, hyperactive presentation, or combined presentation) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2. To confirm that ADHD is the primary diagnosis, the Mini International Neuropsychiatric Interview (MINI) will be used to identify and exclude other psychiatric conditions which would preclude enrollment.
- Subjects are 18 to 55 years of age, inclusive, at the time of consent.
- Subjects have BMI of 18 to 40, inclusive
- Subjects are willing to discontinue all prohibited psychotropic medications starting from the time of signing the informed consent and up to the 10-day safety follow-up period.
Exclusion Criteria:
- Subject has a DSM-5 diagnosis of Other Specified or Unspecified Attention-Deficit/Hyperactivity Disorder as confirmed by ACDS Version 1.2.
- Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this trial or is uncontrolled and associated with significant symptoms, including but not limited to: a current major depressive episode (per DSM-5 criteria), current symptoms (past 90 days) meeting the DSM-5 criteria for a diagnosis of generalized anxiety disorder, obsessive compulsive disorder, panic disorder, or posttraumatic stress disorder, as established by the MINI. NOTE: Subjects with mild mood or anxiety symptoms that do not meet criteria for diagnosis, who do not require treatment based on the Investigator's assessment, and do not confound efficacy or safety assessments in the opinion of the examining Investigator, may be included.
- Subjects that have a positive alcohol test (via breathalyzer or blood), a positive drug screen for cocaine, or other illicit drugs (excluding marijuana). Subjects with a positive drug screen for confirmed prescription medications at baseline will not be permitted to continue participation in Trial 405-201-00015. NOTE: Subjects that tested positive for marijuana may be permitted to be enrolled if they have no evidence of a substance use disorder, and if they agree to refrain from use for the duration of the trial. Allowance for subjects testing positive for marijuana at screening require explicit approval from the medical monitor.
Qualified Participants May Receive:
Compensation for time and travel for all completed study visits for all qualified participants.