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Completed

NCT Number: NCT04479852

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alea Research, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SP-624

Drug

Oral capsule

Placebo

Drug

Oral capsule

Primary outcomes

  1. 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

  1. Change From Baseline to Week 4 in Clinical Global Impression - Severity (CGI-S) Total Score

    Time frame: Baseline to Week 4

    The CGI-S is a 7-point scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A score of 1 represents "normal" and 7 represents "most extremely ill".

  2. Change From Baseline to Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) Total Score

    Time frame: Baseline to Week 4

    The 17-item Hamilton Depression rating scale is used to assess the severity of depression. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=No difficulty/absent and 4=most severe. The total score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.

  3. Change From Baseline to Week 4 in the Sheehan Disability Scale (SDS)

    Time frame: Baseline to Week 4

    The Sheehan Disability Scale is a 3-part scale that measures the degree of disruption on work, social, and family life using an 11-point scale where 0 represents "no disruption" and 10 represents "extreme disruption". Each item (work, social, and family life) can have a score of 0-10. A total global functioning impairment score can be utilized by summing the scores from work, social, and family life scales for a value range from 0 to 30, where a higher score represents a worse outcome, i.e., more disruption on work, social, and family life. In addition to the 11-point scale, participants are asked to indicate the number of days in the past week that were "lost" and numbers of days that were "unproductive". The results of these questions have a range from 0 to 7 and are not included in the overall scale total.

  4. Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR)

    Time frame: Baseline to Week 4

    The Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR), is a 16 item self-reported scale where each item has a 4-point scale where 0 represents least impact scores while 3 represents greatest impact scores. Some questions are linked such that the highest score in a group of questions is entered once. For example, there are 4 questions related to sleep and the highest score on any of the 4 sleep items is entered once. The total score ranges from 0 to 27 where a higher score indicates more depression.

  5. Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

    Time frame: Baseline to Week 4

    The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item satisfaction scale where each item has a 5-point scale. A score of 1 represents "very poor satisfaction", while a score of 5 represents "very good satisfaction". Only the first 14 items are summed for a total score that ranges from 14 to 70, where a lower score represents a worse outcome.

Sponsors and collaborators

Lead sponsor

Sirtsei Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2020
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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