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

Launched by SIRTSEI PHARMACEUTICALS, INC. · Feb 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SP-624 for adults who have Major Depressive Disorder (MDD), a serious condition that affects mood and daily life. The trial is in its second phase, which means researchers are assessing how effective and safe SP-624 is compared to a placebo, which is a substance with no active medication. The study is currently looking for participants aged 18 to 65 who have been diagnosed with moderate to severe depression. To be eligible, participants should generally be in good health, have a body mass index (BMI) between 18 and 45, and not have certain other mental or physical health conditions.

If you choose to participate, you will be monitored closely by healthcare professionals throughout the study. This includes regular check-ins to assess your health and how you are responding to the treatment. It’s important to note that individuals who are pregnant, breastfeeding, or have certain serious medical conditions, like significant heart problems or high blood pressure, will not be eligible to join. This trial aims to provide valuable information that could help improve treatments for depression, benefiting many people in the future.

Gender

ALL

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).