RecruitingPhase 2NCT06254612
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
A Multi-center, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
Sponsor
Sirtsei Pharmaceuticals, Inc.
Enrollment
456 participants
Start Date
Mar 25, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria4
- 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 Criteria5
- 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).
Interventions
DRUGSP-624
Once daily oral administration of two capsules totaling 20 mg/day
DRUGPlacebo
Once daily oral administration of two matching placebo capsules
Locations(50)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06254612
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