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A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: DT-101 (drug), DT-101 (drug), Placebo (drug)
How long the study runs: Study runs about 20 months (dates as stated)
About the drug or intervention: DT-101 — drug: DT-101 A · DT-101 — drug: DT-101 B · Placebo — drug: Placebo
Patient visit burden: Not specified by the sponsor

In plain English

This study, run by Draig Therapeutics Ltd, is looking at how well a treatment called DT-101 works in people with depression. It is for adults aged 18 to 75 with Major Depressive Disorder (MDD), which means depression that has come back after at least one earlier episode.

Who can take part

Able to read, understand and communicate in the language used at the study site, and willing to give written informed consent
Aged 18 to 75 at the time of giving consent. Open to all gender identities
Has had depression that keeps coming back — at least one past episode, not counting the current one, diagnosed using the DSM-5-TR (a guide doctors use to diagnose mental health conditions, 2022 version)

Who may not be able to

Pregnant, breastfeeding, or planning to become pregnant during the study
Has an unstable medical condition or unstable long-term illness
Has a significant problem with the nervous system
Has had a moderate or severe alcohol or drug use problem (as defined by the DSM-5-TR) in the 6 months before screening
Has ever had a seizure
In the researcher's view, is not able to follow what the study asks of them

What taking part involves

• Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 18 Years to 75 Years
Who: All
Number of participants: 300
Started: 2025-12-16
Last checked: 2025-12

Plain English Summary

What is this study?

• Testing a new treatment for major depressive disorder (mdd)
• Phase2 - 300 participants
• The goal of this clinical trial is to learn if DT-101 can treat depression in adults

Who can take part?

• Ages 18 Years to 75 Years
• Diagnosed with major depressive disorder (mdd)

Where?

• Chester - Draig Clinical Site
• Eastbourne - Draig Clinical Site
• Glasgow - Draig Clinical Site
• London - Draig Clinical Site
• +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires.

More detail

The purpose of this study is to compare DT-101 and placebo in adult participants with MDD. The study will also evaluate how safe and well tolerated the study drug is. The clinical study staff will check participants' suitability to take part in the clinical research study by performing physical and neurological examinations, obtaining blood and urine samples, conducting clinical assessments and reviewing medical and treatment history. These tests and assessments will continue throughout the study with the purpose of checking the participants' ongoing suitability and to collect data to analyze the effect that DT-101 may have on their depression symptoms. Participants will also have blood samples taken to allow analysis of how DT-101 is absorbed and used by the body (PK sampling), some blood samples may be retained in order to perform future research that may be useful when looking at whether genetics affects how a person responds to DT-101 (PGx sampling)

Major Depressive Disorder (MDD)

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years - 75 Years
Who can join: All genders

What the study is looking for

✓The participant is able to read, understand and communicate in the local language used at the study site, and is...
✓Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 75 years of age,...
✓Has recurrent depression (defined as at least one prior episode excluding the current one), as diagnosed by DSM 5-TR...

Who cannot take part

✗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.

See the full criteria

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.