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Researchers in Austin, Texas are studying an investigational medicine for adults diagnosed with Major Depressive Disorder.
Adults aged 18–75 with a diagnosis of recurrent MDD are invited to learn more about the TARIAN-1 study.
What is this study?
The TARIAN-1 study is a Phase 2 clinical research study evaluating an investigational once-daily oral capsule in adults who have been diagnosed with Major Depressive Disorder (MDD).
Researchers want to understand how the study medicine behaves in the body and how it compares with a placebo (an inactive capsule). This is a placebo-controlled study, meaning some participants will receive the investigational medicine and some will receive a placebo. Each participant has an equal chance of being assigned to any group.
The study is being conducted at a single research site in Austin, Texas and is overseen by an independent Institutional Review Board (IRB) to protect the rights, safety, and wellbeing of all participants.
No one will be enrolled without their full informed consent. Participation is completely voluntary.
Study at a Glance
- Study Phase
- Phase 2
- Condition
- Major Depressive
Disorder (MDD) - Sponsor
- Draig Therapeutics Ltd
- Managed With
- ICON Plc
- Visits
- ~8 in person + 1 by phone
- Duration
- About 4 months
Who can participate?
You may be eligible for the TARIAN-1 study if you meet the following criteria:
Adults aged 18 to 75 years (inclusive) at the time of consent
Diagnosis of recurrent Major Depressive Disorder (MDD) confirmed under DSM-5-TR criteria, with at least one prior depressive episode (separate from the current episode)
Current depressive episode lasting at least 6 weeks before the screening visit
Not currently taking antidepressant medication, OR willing to stop antidepressant medication before the study baseline visit under medical guidance (a washout period of at least 14 days or 5 half-lives — whichever is longer — is required)
Willing and able to attend approximately 8 clinic visits in Austin, Texas over about 4 months
Have access to email, internet, and/or video call for study-related communication
BMI between 17.5 and 40 kg/m2
Willing and able to use a highly effective method of contraception during the study if applicable (males: from first dose until 3 months after last dose; females of childbearing potential: from first dose until at least 1 week after last dose)
Willing to allow the study team to notify your primary care doctor of your participation, where applicable
If currently in cognitive or behavioural therapy that began more than 6 months ago, willing to continue that therapy unchanged and not start any new therapy during the study
Negative test results for HIV, hepatitis B, and hepatitis C at screening
Think you might be a good fit?
Take a few minutes to see if the TARIAN-1 study is right for you.
Who should not participate?
This study may not be suitable for you if any of the following apply:
History of treatment-resistant depression, defined as continuing depressive symptoms despite two or more antidepressant medication classes taken at an adequate dose for at least 6 weeks each
Continuous depressive episode lasting more than 1 year without remission
Currently pregnant, breastfeeding, or planning to become pregnant during the study period
Any unstable medical condition or unstable chronic disease
Significant neurological disorder or abnormality
Current or past diagnosis of psychosis, schizophrenia, bipolar disorder, mania, or hypomanic episodes
Use of antipsychotic medications or mood stabilisers (including lithium, lamotrigine, carbamazepine, or valproate) in the past 12 months
History or diagnosis of an eating disorder in the past 12 months
Previous treatment with electroconvulsive therapy (ECT) for depression
A history of suicide attempt in the past 24 months, or significant suicide risk as assessed by the study team
History of seizures (note: simple febrile convulsions in childhood are not automatically disqualifying — the study team will advise)
A positive urine drug or alcohol screen at screening. Marijuana use is not permitted during the study.
History of moderate or severe alcohol or drug use disorder in the past 6 months
Participation in any other clinical research study involving an investigational product within the past 24 weeks
Use of St John's Wort within 14 days before the first dose, or use of antiepileptic or sedating medications in the past 6 months
BMI outside the range of 17.5 to 40 kg/m2
What's involved?
Here's what you can expect if you take part in the TARIAN-1 study.
Visit Schedule
The study involves approximately 8 clinic visits to the Austin, Texas research site over about 4 months. Visits are scheduled roughly every 1–2 weeks during the treatment period. One Day 3 contact is by phone only.
At Each Visit
At visits, you may be asked to complete questionnaires about mood and wellbeing, take part in brief cognitive assessments, have blood draws, and have a physical examination and heart rhythm check (ECG). Visit length will vary depending on the assessments scheduled that day — some visits, particularly your first and those at weeks 6 and 8, may last several hours. The study team will give you a full schedule in advance.
Study Medicine
The study medicine is taken as a once-daily oral capsule in the morning on an empty stomach. Your first dose is taken at the clinic. After that, you take the capsule at home each day.
Lifestyle Adjustments
Some lifestyle adjustments are required during the study, including avoiding alcohol for 24 hours before each clinic visit, avoiding grapefruit and St John's Wort, and not using marijuana throughout the study. The study team will explain all requirements clearly before you decide to take part.
Compensation
Participants will receive reimbursement for their time and travel.
Frequently Asked Questions
What is the TARIAN-1 study?
Is this study approved?
Who is sponsoring this study?
What is a placebo-controlled study?
Do I have to stop my current antidepressant to take part?
Not necessarily — but there are two things to consider. First, the study requires that you are not taking antidepressant medication at the start of the treatment period. If you are currently taking an antidepressant, the study team will discuss whether stopping under medical supervision (a washout of at least 14 days or 5 half-lives, whichever is longer) is appropriate for you. Please do not stop any medication without medical guidance.
Second, if you have already tried two or more antidepressant medications from different classes — whether during this episode or a previous one — each for at least 6 weeks at a full dose, and your depression did not adequately respond, you would not be eligible for this study. This applies regardless of whether those treatment attempts were recent or in the past. The study team will go through this with you during screening.
