Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Phone or video check-ins
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well SPN-821 works and how safe it is compared with a placebo, a treatment with no active drug. It is for adults with major depression whose symptoms have not improved enough with their current antidepressant.
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have major depression confirmed by a study interview, without psychosis, such as seeing or hearing things that are not there.
- Your current period of depression has lasted at least 8 weeks.
- Score at least 24 on the MADRS depression rating scale at screening and Day 1.
- Be rated moderately ill or worse on the CGI-S scale at screening and Day 1.
- Take just one study-approved antidepressant at a steady treatment dose for at least 8 weeks before screening and 10 weeks by Day 1.
- Have less than 50% improvement in depression symptoms with your current antidepressant, as confirmed by the study team.
Who can't join
- Your MADRS depression score changes by 25% or more between screening and Day 1.
- During your current period of depression, 3 or more antidepressants have failed to help after at least 8 weeks each at a proper dose.
- Have had an alcohol or drug use disorder in the 6 months before screening.
- The study doctor believes you have a high risk of suicidal behavior during the study.
- Have ever been diagnosed with a psychotic disorder, depression with psychosis or mixed features, bipolar disorder, schizophrenia, post-traumatic stress disorder, or autism; or have a personality disorder or intellectual disability that would affect joining the study.
- Within the past 12 months, were diagnosed with severe obsessive-compulsive disorder, acute stress disorder, panic disorder, an eating disorder, or another mental health condition that was the main focus of treatment; or were diagnosed with generalized anxiety disorder within the past 6 months.
- Have a medical condition that the study doctor believes could make the study unsafe or affect its results, an important abnormal test result before Day 1, or abnormal kidney function.
- Need a medicine or other substance that the study does not allow.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
CA
- Collaborative Neuroscience Network · Garden Grove, CA 92845More trials in Garden Grove