118 Participants Needed

DT-101 for Depression

(AERON-1 Trial)

Recruiting at 17 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Draig Therapeutics Ltd
Prior Safety DataThis treatment has passed at least one previous human trial
3 Power Preferred Clinics3 of this trial's clinics are considered top 20 on Power

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will test whether a study drug called DT-101 can help treat depression in adults with Major Depressive Disorder (MDD). DT-101 will be compared to a placebo. Participants will visit the clinic for health checks and to complete questionnaires. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before and during the trial. The clinical team will work with you throughout the trial to help manage your medications.

Is there any evidence suggesting that DT-101 is likely to be safe for humans?

Research is exploring DT-101 as a potential treatment for major depressive disorder. DT-101 is currently in a Phase 2 trial, indicating it has passed initial safety tests in smaller groups. Researchers are closely monitoring for adverse side effects as more participants try the treatment. Participants in this trial will provide crucial information on the safety of DT-101.

Why do researchers think this study treatment might be promising for depression?

Researchers are interested in DT-101 because it represents a new approach to treating depression. Unlike traditional antidepressants, DT-101 works through a different brain pathway — it acts on glutamate signalling, which is involved in how brain connections form and strengthen. This novel mechanism may offer relief for people who haven't responded well enough to existing medications like SSRIs or SNRIs. In this trial, DT-101 is being studied as an add-on to a person’s current antidepressant, working alongside exisiting treatment rather than replacing it

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Major Depressive Disorder (MDD) who are seeking additional treatment options. Participants should be generally healthy aside from their depression and able to attend clinic visits.

Inclusion Criteria

Are you currently on a stable dose of depression medication that is not helping?

Exclusion Criteria

Is this the first time you’ve been in a period of depression?
Have you ever been diagnosed with Schizophrenia?
Have you ever been diagnosed with Bipolar Disorder?
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 5 weeks
1 visit (in clinic)

Treatment

Regular visits for study drug administration, assessments, and monitoring

8 weeks
7 visits (in clinic)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Certain patients may also have a follow-up phone call 30 days after the end of treatment

2 weeks
1 visit (in clinic)

What Are the Treatments Tested in This Trial?

Interventions

  • DT-101

Trial Overview

The study tests whether a new drug, DT-101, helps treat depression when added to usual care. Participants will be randomly assigned to receive either DT-101 or a placebo (inactive pill), and both groups will have regular health checks.

Who Is Running the Clinical Trial?

Draig Therapeutics Ltd

Lead Sponsor