Major Depressive Disorder (MDD)
Conditions
Brief summary
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of SPN-821 administered twice a week as adjunctive therapy to an approved antidepressant therapy in adult participants with MDD. The study includes a 2-week Screening Period, a 4-week Double blind Treatment Period, and a Safety Follow-up phone call one week after the completion of the Treatment Period.
Interventions
DRUGSPN-821 2400 mg
SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling
DRUGPlacebo
Matched placebo oral tablets
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI * Duration of current MDE of at least 8 weeks * MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit * CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit and Day 1 Visit * Stable, therapeutic dose of one of the following protocol-approved ADTs as a monotherapy for ≥ 8 weeks before the Screening Visit and ≥ 10 weeks at the Day 1 Visit. Additionally, inadequate response to the current ADT (less than 50% improvement in depressive symptoms) as confirmed by the ATRQ Investigator administered.
Exclusion criteria
* MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit * History of treatment resistant depression (TRD) defined as 3 or more failed ADTs of adequate dose (per ATRQ) and duration (at least 8 weeks) for the current MDE * History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit * Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion * Lifetime diagnosis of any psychotic disorder including MDD with psychosis, MDD with mixed features, bipolar I/II disorder, bipolar depression, schizophrenia, posttraumatic stress disorder, autism spectrum disorder, or any personality disorder or intellectual disability that would affect the ability of the participant to enroll in the study * Diagnosis less then 12 months before screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or any other psychiatric condition that has been the primary focus of treatment, or diagnosis of generalized anxiety disorder less then 6 months before screening. * History of cardiovascular, respiratory, gastrointestinal, renal, hepatic, and hematologic disorders, or other medical disorders that could impose undue risk or compromise the study in the Investigator's opinion * Clinically significant abnormal result prior to Day 1 Visit per Investigator's judgment or abnormal renal function. * Requires treatment with a medication or other substance that is prohibited by the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. | 4 weeks | MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 29 in the Clinical Global Impression - Severity of Illness Score (CGI-S). | 4 weeks | CGI-S is a single-item clinician rating of the clinician's assessment of the severity of symptoms in relation to the clinician's total experience with patients with that condition. The CGI-I is rated on a 7-point scale from 1 to 7, where 1 = "normal not at all ill" and 7 = "among the most extremely ill patients". Successful therapy is indicated by a lower overall score. |
Countries
United States
Contacts
CONTACTGianpiera Ceresoli-Borroni, PhD
Outcome results
None listed