300 Participants Needed

DT-101 for Depression

(Tarian-1 Trial)

Recruiting at 15 trial locations
CM
Overseen ByChief Medical Officer
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Draig Therapeutics Ltd
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, DT-101, can help treat depression in adults. Participants will receive either DT-101 or a placebo (a harmless pill with no active treatment) to compare effects. The study includes regular clinic visits for health checks and questionnaires. It suits adults who have experienced depression multiple times. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research has shown that DT-101 was tested on over 60 people in earlier studies. Participants generally tolerated it well, with most not experiencing serious side effects. The most common side effect was mild to moderate muscle discomfort at the application site, similar to BOTOX®. This suggests that DT-101 might be safe for many, though some may feel slight discomfort in certain areas. However, discussing any concerns with a healthcare provider before joining a trial is always important.12345

Why are researchers excited about this trial's treatments?

Most treatments for depression, like SSRIs and SNRIs, work by boosting serotonin or norepinephrine levels in the brain. But DT-101 is different. Researchers are excited about DT-101 because it targets a new pathway in the brain, potentially offering relief to those who don't respond to current medications. Unlike traditional treatments that can take weeks to kick in, DT-101 might work faster, providing quicker relief for patients. This novel approach could mean a major breakthrough for people with treatment-resistant depression.

What evidence suggests that DT-101 might be an effective treatment for depression?

Research shows that DT-101 may help treat depression. In earlier studies, over 60 participants tolerated DT-101 well, and it worked as intended. These studies compared DT-101 to a placebo and found noticeable improvements in symptoms of major depressive disorder (MDD). While more research is needed, these early results suggest that DT-101 could effectively manage depression. Participants in this trial will receive either DT-101 A, DT-101 B, or a placebo to further evaluate its effectiveness.14678

Are You a Good Fit for This Trial?

This trial is for adults with depression, including Major Depressive Disorder. Participants must be able to visit the clinic regularly for health checks and questionnaires.

Inclusion Criteria

I am between 18 and 75 years old.
I have been diagnosed with depression more than once.
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

Exclusion Criteria

I do not have any unstable medical conditions or chronic diseases.
Pregnant or breastfeeding or plans to become pregnant during the study
I have a major nerve or brain problem.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DT-101 or placebo and attend clinic visits every couple of weeks for health checks and questionnaires

12 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DT-101

Trial Overview

The study tests if DT-101 can treat depression compared to a placebo. Subjects will receive either DT-101 or a placebo and their progress will be monitored through regular clinic visits.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: DT-101 BExperimental Treatment1 Intervention
Group II: DT-101 AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Draig Therapeutics Ltd

Lead Sponsor

Citations

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

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 ...

Draig Therapeutics Announces US FDA Clearance of IND ...

The TARIAN-1 study will evaluate the safety and efficacy of DT-101 in people with MDD compared to placebo and the primary endpoint is change in ...

Draig Therapeutics to Initiate Phase 2 Study of DT-101 for ...

The study builds upon positive Phase 1 results from over 60 participants, where DT-101 was well tolerated and demonstrated target engagement ...

Draig Therapeutics Secures FDA Clearance to Launch ...

The TARIAN-1 study will evaluate the safety and efficacy of DT-101 in people with MDD compared to placebo and the primary endpoint is change in the participants ...

FDA clears IND for DT-101 in Major Depressive Disorder

Earlier this year, we published the results of an observational clinical study in individuals with PMS, conducted in collaboration with INGEMM ...

Draig Therapeutics Announces US FDA Clearance of IND ...

The TARIAN-1 study will evaluate the safety and efficacy of DT-101 in people with MDD compared to placebo and the primary endpoint is change in ...

DT-101 - Drug Targets, Indications, Patents

The Phase 2 trial builds on the positive results from a completed Phase 1 programme in over 60 subjects, in which DT-101 was found to be well tolerated and ...

Draig Therapeutics starts Phase 2 trial for DT-101 in MDD

Safety outcomes were consistent with the established BOTOX® profile. The most common adverse event was mild to moderate, localized muscle ...