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RecruitingPhase 2

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)

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

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 65 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

Not stated in the study description — ask the study team about visits and procedures.

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 SPT-300 (GlyphAllo) works for major depression and how safe it is when used alone. It is for adults ages 18 to 65, with or without anxiety along with their depression. The study compares SPT-300 with a placebo, which has no active drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 65 and can understand and sign a form agreeing to join.
  • Major depression must be your main diagnosis. Certain anxiety disorders are allowed if they have not been the focus of treatment in the past 6 months and the study doctor confirms depression is the main condition.
  • Your current period of depression has lasted at least 4 weeks but no more than 18 months before screening.
  • If you can become pregnant, you must not plan pregnancy during the study or be breastfeeding. You must use highly effective birth control during the study and for 30 days after the last dose.
  • Your body mass index (BMI), a measure based on height and weight, is 18 to 40.
  • You are willing and able to avoid drug misuse.

Who can't join

  • You have or have had depression with loss of touch with reality or major movement problems; bipolar disorder or episodes of unusually high energy or mood, including those caused by drugs; schizophrenia or related disorders; obsessive-compulsive disorder; or lasting problems with memory or thinking.
  • Two or more depression treatments, given at a suitable dose for long enough, have failed during your current period of depression.
  • You have been hospitalized for mental health care during your current period of depression.
  • You have or have had a serious illness that could affect your ability to take part.
  • You have had trouble tolerating, an allergy to, or serious side effects from allopregnanolone or any ingredient in SPT-300 or the placebo.
  • You have a history of a drug or alcohol use disorder.
  • You test positive for cannabinoids, substances found in cannabis.
  • You have a serious risk of suicide or of harming yourself or others.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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. * 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 participation in the study and for 30 days after receiving the last dose of study treatment. * 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. Exclusion Criteria: * History of, or current presentation consistent with: 1. any depressive episode with psychotic or catatonic features. 2. any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode. 3. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression. 4. schizophrenia, schizoaffective, or other psychotic disorder. 5. obsessive-compulsive disorder. 6. 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.

Study sites (29)

CA

CT

FL

GA

MA

MO

NY

OH

PA

TX

WA