RecruitingNCT07065240ClinicalTrials.gov record

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)

Major Depressive Disorder (MDD) · Major Depressive Disorder With Anxious Distress

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 2
Age range: 18 years - 65 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 360 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Quadruple masked

SPT-300

Participants will receive SPT-300 capsules once daily for 42 days

Drug: SPT-300

Placebo

Participants will receive matching placebo once daily for 42 days

Drug: Placebo

SPT-300 DRUG

A prodrug of allopregnanolone, a small molecule drug

Placebo DRUG

Placebo for SPT-300

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score

Time frame: Baseline (Day 0) to Day 42

HAM-D-17 is a 17-item, clinician-administered rating scale to assess the severity of symptoms in participants diagnosed with depression. The HAM-D-17 comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. HAM-D Total Scores range from 0 to 52, with higher scores indicating more severe depression.

Secondary measures

Change From Baseline to Day 42 in Clinical Global Impression - Severity (CGI-S)

Time frame: Baseline (Day 0) to Day 42

The CGI-S is a clinician-administered rating scale to assess the severity of the participant's illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. Scores range from 1 to 7, with higher scores indicating more severe illness.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (62)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

62 locations

Seaport Investigator SiteChino, California, United StatesRecruiting