Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SPN-821 2400 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SPN-821 as an Adjunctive Therapy in Adults With Major Depressive Disorder
Overview
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
- Drug SPN-821 2400 mg
SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling - Drug Placebo
Matched placebo oral tablets
Primary outcome measures
- Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. [Time frame: 4 weeks]
Secondary outcome measures (1)
- Change From Baseline to Day 29 in the Clinical Global Impression - Severity of Illness Score (CGI-S). [Time frame: 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Collaborative Neuroscience Network — Garden Grove
Identifiers
NCT: NCT07226661 · 821P203