A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults with Major Depressive Disorder
Purpose
This is a Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.
Condition
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Males and females, aged 18 to 65 years, inclusive. - Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI). - In generally good physical health, in the opinion of the Investigator. - Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m2.
Exclusion Criteria
- Female who is pregnant, breastfeeding, or less than 6 months postpartum at screen. - A history of or current DSM-5 diagnosis of MDD with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder. - Presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension. - Presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (SBP) >160 mmHg or consistent sitting diastolic blood pressure (DBP) >95 mmHg despite present therapy. - Screening laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, thyroid function, and urinalysis).
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 SP-624 |
Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg |
|
|
Placebo Comparator Placebo |
Participant to receive 2 matching placebo capsules once daily |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Sirtsei Pharmaceuticals, Inc.
