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)
Purpose
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.
Conditions
- Major Depressive Disorder (MDD)
- Major Depressive Disorder With Anxious Distress
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SPT-300 |
Participants will receive SPT-300 capsules once daily for 42 days |
|
|
Placebo Comparator Placebo |
Participants will receive matching placebo once daily for 42 days |
|
Recruiting Locations
Seaport Investigator Site
Chino, California 91710
Chino, California 91710
Seaport Investigator Site
Garden Grove, California 92845-2506
Garden Grove, California 92845-2506
Seaport Investigator Site
Glendale, California 91206
Glendale, California 91206
Seaport Investigator Site
Redlands, California 92373
Redlands, California 92373
Seaport Investigator Site
San Jose, California 95124
San Jose, California 95124
Seaport Investigator Site
Cromwell, Connecticut 06416
Cromwell, Connecticut 06416
Seaport Investigator Site
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Seaport Investigator Site
Lauderhill, Florida 33319
Lauderhill, Florida 33319
Seaport Investigator Site
Orlando, Florida 32801
Orlando, Florida 32801
Seaport Investigator Site
Palm Bay, Florida 32905
Palm Bay, Florida 32905
Seaport Investigator Site
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
Seaport Investigator Site
Atlanta, Georgia 30328
Atlanta, Georgia 30328
Seaport Investigator Site
Decatur, Georgia 30030
Decatur, Georgia 30030
Seaport Investigator Site
Marietta, Georgia 30060
Marietta, Georgia 30060
Seaport Investigator Site
Boston, Massachusetts 02116
Boston, Massachusetts 02116
Seaport Investigator Site
Boston, Massachusetts 02131
Boston, Massachusetts 02131
Seaport Investigator Site
Russells Mills, Massachusetts 02747
Russells Mills, Massachusetts 02747
Seaport Investigator Site
St Louis, Missouri 63141
St Louis, Missouri 63141
Seaport Investigator Site
Brooklyn, New York 11235
Brooklyn, New York 11235
Seaport Investigator Site
Cedarhurst, New York 11516
Cedarhurst, New York 11516
Seaport Investigator Site
New York, New York 10029
New York, New York 10029
Seaport Investigator Site
Staten Island, New York 10314
Staten Island, New York 10314
Seaport Investigator Site
Independence, Ohio 44131
Independence, Ohio 44131
Seaport Investigator Site
North Canton, Ohio 44720
North Canton, Ohio 44720
Seaport Investigator Site
Allentown, Pennsylvania 18104
Allentown, Pennsylvania 18104
Seaport Investigator Site
Media, Pennsylvania 19063
Media, Pennsylvania 19063
Seaport Investigator Site
Dallas, Texas 75231
Dallas, Texas 75231
Seaport Investigator Site
Irving, Texas 75062
Irving, Texas 75062
Seaport Investigator Site
Richardson, Texas 75080
Richardson, Texas 75080
Seaport Investigator Site
Everett, Washington 98201
Everett, Washington 98201
More Details
- Status
- Recruiting
- Sponsor
- Seaport Therapeutics