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

NCT04479852 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SP-624-201
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 39

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 4

Secondary Outcomes (5)

• 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

Study Arms (2)

SP-624

EXPERIMENTAL

Daily oral capsule, 20 mg/day

Drug: SP-624

Placebo

PLACEBO COMPARATOR

Daily oral capsule

Drug: Placebo

Interventions

SP-624 DRUG

Oral capsule

SP-624

Placebo DRUG

Oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sirtsei Pharmaceuticals, Inc.: lead

Study Sites (39)

Alea Research

Phoenix, Arizona, 85012, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Collaborative Neuroscience Research

Garden Grove, California, 92845, United States

Location

Pacific Research Partners

Oakland, California, 94607, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Collaborative Neuroscience Research

Torrance, California, 90502, United States

Location

MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Innovative Clinical Research

Lauderhill, Florida, 33319, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Institute for Advanced Medical Research

Alpharetta, Georgia, 30022, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

American Medical Research

Chicago, Illinois, 60612, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

SPRI Clinical Trials

Brooklyn, New York, 11235, United States

Location

Manhattan Behavioral Medicine

New York, New York, 10036, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

Location

Clinical Trials of America

Hickory, North Carolina, 28601, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Oregon Center for Clinical Investigations

Portland, Oregon, 97214, United States

Location

Oregon Center for Clinical Investigations

Salem, Oregon, 97301, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Donald J. Garcia, Jr., MD, PA

Austin, Texas, 78737, United States

Location

Future Search Trials of Dallas

Dallas, Texas, 75231, United States

Location

Red Oak Psychiatry Associates

Houston, Texas, 77090, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Greg Rigdon, PhD
• Organization: Sirtsei Pharmaceuticals

grigdon@arrivobio.com

+1 919-949-6862

Study Officials

• Greg Rigdon, PhD

  Sirtsei Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: September 30, 2020
• Primary Completion: June 27, 2022
• Study Completion: August 9, 2022
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2024-08

Locations

US (39)