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

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: SP-624; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 319
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Alea Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest
  • California
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Research
    • Oakland, California, United States, 94607
      • Pacific Research Partners
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Torrance, California, United States, 90502
      • Collaborative Neuroscience Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Lauderhill, Florida, United States, 33319
      • Innovative Clinical Research
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Institute for Advanced Medical Research
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60612
      • American Medical Research
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • Midwest Research Group
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research Institute
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials
    • New York, New York, United States, 10036
      • Manhattan Behavioral Medicine
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • New Hope Clinical Research
    • Hickory, North Carolina, United States, 28601
      • Clinical Trials of America
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Cutting Edge Research Group
  • Oregon
    • Portland, Oregon, United States, 97214
      • Oregon Center for Clinical Investigations
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigations
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • Austin, Texas, United States, 78737
      • Donald J. Garcia, Jr., MD, PA
    • Dallas, Texas, United States, 75231
      • Future Search Trials of Dallas
    • Houston, Texas, United States, 77090
      • Red Oak Psychiatry Associates
    • Wichita Falls, Texas, United States, 76309
      • Grayline Research Center
  • Washington
    • Everett, Washington, United States, 98201
      • Core Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SP-624; Daily oral capsule, 20 mg/day	Drug: SP-624; Oral capsule
Placebo Comparator: Placebo; Daily oral capsule	Drug: Placebo; Oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) total score	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.	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Weeks 1, 2, and 3 in Montgomery Asberg Depression Rating Scale total score	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.	Up to 3 weeks
Change from Baseline to Weeks 1, 2, 3, and 4 in Clinical Global Impression - Severity (CGI-S) total score	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".	Up to 4 weeks
Change from Baseline to Week 5 and change from Week 4 to Week 5 in MADRS total score	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.	Up to 5 weeks
Change from Baseline to Week 5 and change from Week 4 to Week 5 in CGI-S total score	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".	Up to 5 weeks
Change from Baseline to Week 2 and Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) total score	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.	Up to 4 weeks
Change from Baseline to Week 2 and Week 4 in the Sheehan Disability Scale (SDS)	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". 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. 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.	Up to 4 weeks
Change from Baseline to Week 2 and Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR)	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. The total score ranges from 0 to 27 where a higher score indicates more depression.	Up to 4 weeks
Change from Baseline to Week 2 and Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)	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.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: Sirtsei Pharmaceuticals, Inc.
• Investigators: Study Director: Greg Rigdon, PhD, Sirtsei Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): June 27, 2022
• Study Completion (Actual): June 27, 2022

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: SP-624-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No