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

NCT06254612 | Recruiting Phase 2 FDA Drug

• 1 other identifier: SP-624-202
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 50

Brief Summary

This is a Phase 2B clinical study evaluating the effectiveness and safety 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 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

  The MADRS is a 10-item depression rating scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The toal 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 (7)

• Change from Baseline in the Clinical Global Impression - Severity (CGI-S) score.

  Baseline to Weeks 1-4 and 1- and 2- Week Follow-up

• Change from Baseline in Quick Inventory of Depressive Symptomology-Self-Report (QIDS-SR) total score.

  Baseline to Weeks 1-4 and 1- and 2- Week Follow-up

• Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

  Baseline to Weeks 1-3 and 1- and 2- Week Follow-up

• Change from Baseline in 17-item-Hamilton Depression Rating Scale (HAM-D-17) total score.

  Baseline to Weeks 2 and 4

• Change from Baseline in Sheehan Disability Scale (SDS) total score.

  Baseline to Weeks 2 and 4

Study Arms (2)

SP-624

EXPERIMENTAL

Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg

Drug: SP-624

Placebo

PLACEBO COMPARATOR

Participant to receive 2 matching placebo capsules once daily

Drug: Placebo

Interventions

SP-624 DRUG

Once daily oral administration of two capsules totaling 20 mg/day

SP-624

Placebo DRUG

Once daily oral administration of two matching placebo capsules

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:

• Males and females, aged 18 to 65 years, inclusive.
• Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
• In generally good physical health, in the opinion of the Investigator.
• Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m2.

You may not qualify if:

• Female who is pregnant, breastfeeding, or less than 6 months postpartum at screen.
• A history of or current DSM-5 diagnosis of MDD with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder.
• Presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension.
• Presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (SBP) \>160 mmHg or consistent sitting 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, thyroid function, and urinalysis).

Sponsors & Collaborators

• Sirtsei Pharmaceuticals, Inc.: lead
• Rho, Inc.: collaborator

Study Sites (50)

IMA Clinical Research

Phoenix, Arizona, 85012, United States

RECRUITING

Noble Clinical Research

Tucson, Arizona, 85704, United States

RECRUITING

SanRo Clinical Research Group

Bryant, Arkansas, 72022, United States

RECRUITING

Clinical Innovations

Bellflower, California, 90706, United States

RECRUITING

Sun Valley Research Center

Imperial, California, 92251, United States

RECRUITING

Synergy San Diego

Lemon Grove, California, 91945, United States

RECRUITING

Excell Research

Oceanside, California, 92056, United States

RECRUITING

CiTrials

Riverside, California, 92506, United States

RECRUITING

Collaborative Neuroscience Research

Torrance, California, 90504, United States

RECRUITING

Sunwise Clinical Research

Walnut Creek, California, 94596, United States

RECRUITING

Next Level Clinical Trials

West Covina, California, 91790, United States

RECRUITING

MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

RECRUITING

Clinical Neuroscience Solutions

Jacksonville, Florida, 32256, United States

RECRUITING

Accel Clinical

Lakeland, Florida, 33803, United States

COMPLETED

Segal Trials

Lauderhill, Florida, 33319, United States

RECRUITING

Segal Trials - Miami Lakes

Miami Lakes, Florida, 33016, United States

COMPLETED

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

RECRUITING

DMI Research

Pinellas Park, Florida, 33782, United States

RECRUITING

Accelerated Enrollment Solutions

Atlanta, Georgia, 30328, United States

RECRUITING

Velocity Clinical Research

Meridian, Idaho, 83642, United States

COMPLETED

Revive Research Institute

Elgin, Illinois, 60123, United States

RECRUITING

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

RECRUITING

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

RECRUITING

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States

RECRUITING

Midwest Research Group

Saint Charles, Missouri, 63304, United States

RECRUITING

Alivation Research

Lincoln, Nebraska, 68526, United States

COMPLETED

IMA Clinical Research

Las Vegas, Nevada, 89102, United States

RECRUITING

Redbird Research

Las Vegas, Nevada, 89119, United States

RECRUITING

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

RECRUITING

CenExel HRI

Marlton, New Jersey, 08053, United States

ACTIVE NOT RECRUITING

IMA Clinical Research

Albuquerque, New Mexico, 87109, United States

COMPLETED

Integrative Clinical Trials

Brooklyn, New York, 11229, United States

RECRUITING

Pioneer Clinical Research

New York, New York, 10016, United States

RECRUITING

Magnolia Clinical Research

Cary, North Carolina, 27511, United States

RECRUITING

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

RECRUITING

Velocity Clinical Research

Beachwood, Ohio, 44122, United States

COMPLETED

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

COMPLETED

North Star Medical Research

Middleburg Heights, Ohio, 44130, United States

RECRUITING

Summit Headlands

Portland, Oregon, 97210, United States

RECRUITING

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

COMPLETED

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

RECRUITING

Donald J. Garcia, Jr, MD, PA

Austin, Texas, 78737, United States

RECRUITING

Future Search Trials of Dallas

Dallas, Texas, 75231, United States

COMPLETED

Haracec Clinical Research

El Paso, Texas, 79902, United States

RECRUITING

Pillar Clinical Research

Richardson, Texas, 75080, United States

COMPLETED

R and H Clinical Research

Stafford, Texas, 77477, United States

RECRUITING

Grayline Research Center

Wichita Falls, Texas, 76309, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

Core Clinical Research

Everett, Washington, 98201, United States

RECRUITING

Related Publications (1)

• Raskin J, Clayton AH, Kornstein SG, Papakostas GI, Prescott Y, Abernathy K, Hall J, Ackermann M, Wargin W, Rigdon G; SP-624-201 study investigators. A phase 2, multicenter, double-blind, randomized, placebo-controlled study of the safety and efficacy of forvisirvat (SP-624) in the treatment of adults with major depressive disorder. Curr Med Res Opin. 2025 Sep;41(9):1723-1734. doi: 10.1080/03007995.2025.2574465. Epub 2025 Oct 29.

  PMID: 41099447 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Greg Rigdon, PhD

  Sirtsei Pharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

Yuki Prescott

CONTACT

919-460-9500; yprescott@arrivobio.com

Study Design

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

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (50)