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New treatment option for Major Depressive Disorder (MDD)
Official title Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
ClinicalTrials.gov ID: NCT07226661
What this study is testing
What is SPN-821 2400 mg?
SPN-821 2400 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for major depressive disorder (mdd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Diagnosis less then 12 months before screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or...
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Garden Grove, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garden Grove, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.