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

NCT06254612

CompletedPhase 2

Sponsor: Sirtsei Pharmaceuticals, Inc.

Conditions: Major Depressive Disorder

Interventions: SP-624, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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).
Locations (50)
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Bryant, Arkansas, United States
  • Bellflower, California, United States
  • Imperial, California, United States
  • Lemon Grove, California, United States
  • Oceanside, California, United States
  • Riverside, California, United States
  • Torrance, California, United States
  • Walnut Creek, California, United States
  • West Covina, California, United States
  • Colorado Springs, Colorado, United States
  • Jacksonville, Florida, United States
  • Lakeland, Florida, United States
  • Lauderhill, Florida, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • Pinellas Park, Florida, United States
  • Atlanta, Georgia, United States
  • Meridian, Idaho, United States
  • Elgin, Illinois, United States
  • Marrero, Louisiana, United States
  • Boston, Massachusetts, United States
  • Bloomfield Hills, Michigan, United States
  • Saint Charles, Missouri, United States
  • Lincoln, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Las Vegas, Nevada, United States
  • Cherry Hill, New Jersey, United States
  • Marlton, New Jersey, United States
  • + 20 more on CT.gov