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New depression drug DT-101 enters Mid-Stage trial

NCT ID NCT07610473

Symptom relief Sponsor: Draig Therapeutics Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 03, 2026 · Updated 9 times

Summary

This phase 2 trial tests whether DT-101 can ease depression symptoms in adults with major depressive disorder who are already on antidepressant medication. About 118 participants will receive either DT-101 or a placebo, and researchers will track changes in depression scores over 56 days. The goal is to see if DT-101 offers additional benefit beyond standard treatment.

What this could mean

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

Active substance
DT-101
What this could lead to
If it works, this could provide a new treatment option for people with major depressive disorder who are already on medication.
What could go wrong
This is an early-phase trial with only 118 participants, so results may not apply to everyone. The drug may not work better 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

About 118 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2027

An estimate. End dates often move.

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 75 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.

Inclusion Criteria: * The participant is able to read, understand and communicate in the local language used at the study site, and is willing to provide written informed consent * Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 75 years of age, inclusive at the time of signing the informed consent. * Has recurrent depression (defined as at least one prior episode excluding the current one), as diagnosed by DSM 5-TR (Diagnostic and Statistical Manual of Mental Disorders, 2022). Exclusion Criteria: * Pregnant or breastfeeding or plans to become pregnant during the study. * Unstable medical condition or unstable chronic disease. * Significant neurological abnormality. * History of moderate or severe alcohol or drug use disorder as per DSM-5-TR in the 6 months prior to Screening. * History of seizure. * In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder

As listed by the trial registrant

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

Major depressive disorder (MDD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    23 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Draig Clinical Site

    RECRUITING

    Phoenix, Arizona, 85013, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Bellflower, California, 90706, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Costa Mesa, California, 92626, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Lafayette, California, 94549, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Hialeah, Florida, 33016, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Orlando, Florida, 32803, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Orlando, Florida, 32807, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Tampa, Florida, 33607, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Tampa, Florida, 33613, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Decatur, Georgia, 30030, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Chicago, Illinois, 60610, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Skokie, Illinois, 60076, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Boston, Massachusetts, 02130, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    New York, New York, 10025, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    New York, New York, 10029, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Columbus, Ohio, 43215, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Media, Pennsylvania, 19063, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    DeSoto, Texas, 75115, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Bellevue, Washington, 98007, United States

    Contact Email: •••••@•••••

  • Draig Clinical Site

    RECRUITING

    Seattle, Washington, 98104, United States

    Contact Email: •••••@•••••

More trials for these conditions

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