BridgeMD
A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults with Major Depressive Disorder (MDD), with or without Anxious Distress
EU CTIS ID: 2025-521240-37-00
What this study is testing
To characterize the effects of SPT-300 as a monotherapy on depressive symptoms in participants with MDD, with or without anxious distress
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent.
- Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline.
- Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.
You likely can't join if
- History of, or current presentation consistent with: a. any depressive episode with psychotic or catatonic features b. any bipolar manic, hypomanic or mixed episode, and substance-induced (eg, antidepressant-induced) manic, hypomanic/mixed episode c. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression d. schizophrenia, schizoaffective, or other psychotic disorder e. obsessive-compulsive disorder f. any persistent neurocognitive disorder
- Psychiatric hospitalization within current depressive episode. Participants with MDD that requires hospitalization are not eligible for the study.
- Evidence or history of clinically significant disease which can affect the patients’ participation.
- Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300/placebo formulation.
- Participant has a history of drug or alcohol use disorder.
- Participants with a positive test for cannabinoids.
See the full eligibility criteria
- Participant is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent.
- Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline.
- Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.
- History of, or current presentation consistent with: a. any depressive episode with psychotic or catatonic features b. any bipolar manic, hypomanic or mixed episode, and substance-induced (eg, antidepressant-induced) manic, hypomanic/mixed episode c. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression d. schizophrenia, schizoaffective, or other psychotic disorder e. obsessive-compulsive disorder f. any persistent neurocognitive disorder
- Psychiatric hospitalization within current depressive episode. Participants with MDD that requires hospitalization are not eligible for the study.
- Evidence or history of clinically significant disease which can affect the patients’ participation.
- Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300/placebo formulation.
- Participant has a history of drug or alcohol use disorder.
- Participants with a positive test for cannabinoids.
- Clinically significant risk of suicide or harm to self or others.
- History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode.
- Borderline or antisocial personality disorder or other disorder of sufficient severity that judged by the Investigator could interfere with participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- New Zealand
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; New Zealand. 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 EU CTIS; the study team decides eligibility.