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NCT06254612 | RECRUITING | Major Depressive Disorder

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

Sirtsei Pharmaceuticals, Inc.

Location

RECRUITING

United States, California

Sun Valley Research Center

Imperial, California, United States, 92251

Brief 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.

Condition or disease

Major Depressive Disorder

Intervention/treatment

SP-624

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 456 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-03-25
Estimated Primary Completion Date : 2025-09-30
Estimated Study Completion Date : 2025-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

Location Details

NCT06254612

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