A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

Sirtsei Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: SP-624; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06254612

SP-624-202

Details and patient eligibility

About

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.

Enrollment: 456 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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456 participants in 2 patient groups, including a placebo group

SP-624

Experimental group

Description:

Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg

Treatment:

Drug: SP-624

Placebo

Placebo Comparator group

Description:

Participant to receive 2 matching placebo capsules once daily

Treatment:

Drug: Placebo