Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sirtsei Pharmaceuticals, Inc.
With
Rho, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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).
Clareo Health | A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
