A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder

Sirtsei Pharmaceuticals, Inc.34 sites in 1 country319 target enrollmentSeptember 30, 2020

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: 319
Locations: 34
Primary Endpoint: Change From Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 2 clinical study evaluating the safety and effectiveness of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.

Registry

clinicaltrials.gov

Start Date

September 30, 2020

End Date

August 9, 2022

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sirtsei Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to provide written informed consent to participate in the study
•Males and females, aged 18 to 65 years
•In generally good physical health
•Body mass index (BMI) must be between 18 and 40 kg/m2
•Females of reproductive potential and males with partners of reproductive potential must agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug
•Subjects must meet criteria for moderate to severe Major Depressive Disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI)
•Willing and able to comply with the study design schedule and other requirements

Exclusion Criteria

•Female who is pregnant, breastfeeding, or less than six months postpartum at Screening
•History or presence of any clinically significant medical condition, disease, or surgical history that could jeopardize the safety of the subject or validity of the study data, or interfere with the absorption, distribution, metabolism, or excretion of the study drug
•Failure to discontinue all psychoactive medications or psychoactive supplements including antidepressants and mood stabilizers, within a time period prior to Baseline corresponding to at least five half-lives of the medication in question
•Presence of a clinically significant abnormality on physical examination or electrocardiogram (ECG), including a corrected QT interval using Fridericia's formula (QTcF) \>450 msec for males and \>470 msec for females
•Presence of uncontrolled hypertension, defined as consistent systolic blood pressure (SBP) \>160 mmHg or consistent 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, coagulation, and urinalysis)
•Screening liver function tests (ALT, AST, Alkaline phosphatase) \> 2x the upper limit of normal
•Subjects who, in the opinion of the Investigator, are not suitable candidates for the study

Arms & Interventions

SP-624

Daily oral capsule, 20 mg/day

Intervention: SP-624

Placebo

Daily oral capsule

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score

Time Frame: Baseline to Week 4

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

Secondary Outcomes

Change From Baseline to Week 4 in Clinical Global Impression - Severity (CGI-S) Total Score(Baseline to Week 4)
Change From Baseline to Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) Total Score(Baseline to Week 4)
Change From Baseline to Week 4 in the Sheehan Disability Scale (SDS)(Baseline to Week 4)
Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR)(Baseline to Week 4)
Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(Baseline to Week 4)