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

  • STATUS
    Recruiting
  • days left to enroll
    16
  • participants needed
    300
  • sponsor
    Sirtsei Pharmaceuticals, Inc.
Updated on 10 October 2021
body mass index
major depressive disorder

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.

Details
Condition Major depression, Endogenous depression, major depressive disorder, major depressive disorders
Treatment Placebo, SP-624
Clinical Study IdentifierNCT04479852
SponsorSirtsei Pharmaceuticals, Inc.
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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
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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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