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New depression pill SP-624 enters Mid-Stage trial

NCT ID NCT06254612

Symptom relief Sponsor: Sirtsei Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests whether a daily oral drug called SP-624 can safely reduce depression symptoms in adults with major depressive disorder. About 456 participants will receive either SP-624 or a placebo for several weeks. The main goal is to see if SP-624 leads to a greater improvement in depression scores compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SP-624 (a drug taken as a daily capsule)
What this could lead to
If successful, this could lead to a new oral medication option for people with major depressive disorder.
What could go wrong
This is a mid-stage (Phase 2) trial, so results are still uncertain. The drug may not prove more effective than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

497 people

The number who actually took part.

Started

Mar 2024

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

Contacts and locations

Locations

  • Accel Clinical

    Lakeland, Florida, 33803, United States

  • Accelerated Enrollment Solutions

    Atlanta, Georgia, 30328, United States

  • Alivation Research

    Lincoln, Nebraska, 68526, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • CenExel HRI

    Marlton, New Jersey, 08053, United States

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002, United States

  • CiTrials

    Riverside, California, 92506, United States

  • Clinical Innovations

    Bellflower, California, 90706, United States

  • Clinical Neuroscience Solutions

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions

    Memphis, Tennessee, 38119, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • Collaborative Neuroscience Research

    Torrance, California, 90504, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • DMI Research

    Pinellas Park, Florida, 33782, United States

  • Donald J. Garcia, Jr, MD, PA

    Austin, Texas, 78737, United States

  • Excell Research

    Oceanside, California, 92056, United States

  • Future Search Trials of Dallas

    Dallas, Texas, 75231, United States

  • Grayline Research Center

    Wichita Falls, Texas, 76309, United States

  • Haracec Clinical Research

    El Paso, Texas, 79902, United States

  • IMA Clinical Research

    Phoenix, Arizona, 85012, United States

  • IMA Clinical Research

    Las Vegas, Nevada, 89102, United States

  • IMA Clinical Research

    Albuquerque, New Mexico, 87109, United States

  • Integrative Clinical Trials

    Brooklyn, New York, 11229, United States

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910, United States

  • Magnolia Clinical Research

    Cary, North Carolina, 27511, United States

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417, United States

  • Midwest Research Group

    Saint Charles, Missouri, 63304, United States

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan, 48302, United States

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211, United States

  • Next Level Clinical Trials

    West Covina, California, 91790, United States

  • Noble Clinical Research

    Tucson, Arizona, 85704, United States

  • North Star Medical Research

    Middleburg Heights, Ohio, 44130, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Pillar Clinical Research

    Richardson, Texas, 75080, United States

  • Pioneer Clinical Research

    New York, New York, 10016, United States

  • R and H Clinical Research

    Stafford, Texas, 77477, United States

  • Redbird Research

    Las Vegas, Nevada, 89119, United States

  • Revive Research Institute

    Elgin, Illinois, 60123, United States

  • SanRo Clinical Research Group

    Bryant, Arkansas, 72022, United States

  • Segal Trials

    Lauderhill, Florida, 33319, United States

  • Segal Trials - Miami Lakes

    Miami Lakes, Florida, 33016, United States

  • Summit Headlands

    Portland, Oregon, 97210, United States

  • Sun Valley Research Center

    Imperial, California, 92251, United States

  • Sunwise Clinical Research

    Walnut Creek, California, 94596, United States

  • Synergy San Diego

    Lemon Grove, California, 91945, United States

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Velocity Clinical Research

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research

    Beachwood, Ohio, 44122, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.