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Tests treatment safety and results for Major Depressive Disorder (MDD)
Official title A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)
ClinicalTrials.gov ID: NCT07065240
What this study is testing
What is SPT-300?
SPT-300 is an investigational medicine, being studied as a potential treatment for major depressive disorder (mdd).
Also referred to as LYT-300, GlyphAllo.
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 is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.
- 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 65
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...
- Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.
- Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP agree to...
- Body mass index (BMI) between 18 to 40 kg/m2, inclusive.
You likely can't join if
- History of, or current presentation consistent with:
- any depressive episode with psychotic or catatonic features.
- any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode.
- bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.
- schizophrenia, schizoaffective, or other psychotic disorder.
- obsessive-compulsive disorder.
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...
- Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.
- Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP agree to use an acceptable form of highly effective contraception during...
- Body mass index (BMI) between 18 to 40 kg/m2, inclusive.
- Participant is willing and able to refrain from the use of drugs of abuse.
- History of, or current presentation consistent with:
- any depressive episode with psychotic or catatonic features.
- any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode.
- bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.
- schizophrenia, schizoaffective, or other psychotic disorder.
- obsessive-compulsive disorder.
- any persistent neurocognitive disorder.
- History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode.
- Psychiatric hospitalization within current depressive episode.
- Evidence or history of clinically significant diseases 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chino, California, United States
- Garden Grove, California, United States
- Glendale, California, United States
- Redlands, California, United States
- San Jose, California, United States
- Cromwell, Connecticut, United States
- Jacksonville, Florida, United States
- Lauderhill, Florida, United States
- Orlando, Florida, United States
- Palm Bay, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Marietta, Georgia, United States
- Boston, Massachusetts, United States
- Russells Mills, Massachusetts, United States
- St Louis, Missouri, United States
- Brooklyn, New York, United States
- Cedarhurst, New York, United States
- New York, New York, United States
+ 33 more site(s).
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chino, California, United States; Garden Grove, California, United States; Glendale, California, United States; Redlands, California, United States; San Jose, California, United States; Cromwell, Connecticut, United States and 47 more location(s). 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.