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

Sirtsei Pharmaceuticals, Inc.45 sites in 1 country456 target enrollmentMarch 25, 2024

ConditionsMajor Depressive Disorder

InterventionsSP-624 Placebo

DrugsSP-624 Placebo

Overview

Phase: Phase 2
Intervention: SP-624
Conditions: Major Depressive Disorder
Sponsor: Sirtsei Pharmaceuticals, Inc.
Enrollment: 456
Locations: 45
Primary Endpoint: Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
Status: Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 25, 2024

End Date

July 1, 2026

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sirtsei Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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/m

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).

Arms & Interventions

SP-624

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

Intervention: SP-624

Placebo

Participant to receive 2 matching placebo capsules once daily

Intervention: Placebo

Outcomes

Primary Outcomes

Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

Time Frame: Baseline to Week 4

The MADRS is a 10-item depression rating scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The toal score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.

Secondary Outcomes

Change from Baseline in the Clinical Global Impression - Severity (CGI-S) score.(Baseline to Weeks 1-4 and 1- and 2- Week Follow-up)
Incidence rates of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to withdrawal from study.(Baseline to Weeks 1-4 and 1- and 2- Week Follow up)
Change from Baseline in Quick Inventory of Depressive Symptomology-Self-Report (QIDS-SR) total score.(Baseline to Weeks 1-4 and 1- and 2- Week Follow-up)
Change from Baseline in Symbol Digit Modalities Test (SDMT) score.(Baseline to Weeks 2 and 4)
Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.(Baseline to Weeks 1-3 and 1- and 2- Week Follow-up)
Change from Baseline in 17-item-Hamilton Depression Rating Scale (HAM-D-17) total score.(Baseline to Weeks 2 and 4)
Change from Baseline in Sheehan Disability Scale (SDS) total score.(Baseline to Weeks 2 and 4)