TARIAN-1 Major Depressive Disorder Research Study

Full Name

Email Address

Phone Number

Date of Birth

Format: Month/Day/Year (e.g., 01/15/1990)

City and State You Live In

Are you willing to be contacted about future research studies?

Yes No

What types of studies would you be interested in?

List comma separated keywords

Are you able to understand and provide written informed consent?

Yes No

Have you been diagnosed with Major Depressive Disorder (MDD)?

Yes No

Have you experienced at least one previous depressive episode prior to your current episode?

Yes No

Has your current depressive episode lasted at least 6 weeks?

Yes No

Are you currently taking antidepressant medication?

Yes No

This study requires that participants are not taking antidepressant medication at the time the study begins. If your doctor agrees it is medically appropriate, would you be willing to stop taking antidepressant medication before your first study visit?

Yes No

Stopping medication should only happen under the guidance of your doctor — the study team will not ask you to stop medication without medical supervision.

Height (in inches):

Height and weight are used to compute BMI; eligibility requires BMI between 17.5 and 40.

Approximate weight (in pounds):

Are you willing to use a highly effective method of contraception during the study if this applies to you?

Yes No Not applicable

Are you willing and able to attend all required study visits and follow all study procedures?

Yes No

Do you have access to email, the internet, and/or video call capability for study-related communication?

Yes No

Are you willing to allow the study team to notify your primary care doctor of your participation in this study, where applicable?

Yes No

Are you currently receiving formal cognitive or behavioral therapy (such as CBT) or systemic psychotherapy?

Yes No

When did you start your current therapy?

More than 6 months ago Within the last 6 months

Are you willing to continue your current therapy unchanged throughout the study and not start any new therapy during the study?

Yes No

Have you previously tried two or more different antidepressant medications — each taken at a full dose for at least 6 weeks — without meaningful improvement?

Yes No

This includes antidepressants tried during your current episode or any previous episode.

Have you experienced continuous depression lasting longer than 1 year without any period of remission?

Yes No

Are you currently pregnant, breastfeeding, or planning to become pregnant during the study period?

Yes No Not applicable

Do you currently have any unstable medical condition or unstable chronic disease?

Yes No

Have you ever been diagnosed with a significant neurological disorder or condition affecting the brain or nervous system?

Yes No

Have you ever been diagnosed with psychosis, schizophrenia, bipolar disorder, mania, or hypomania?

Yes No

Have you used antipsychotic medication or mood stabilizers (such as lithium, lamotrigine, carbamazepine, or valproate) in the past 12 months?

Yes No

Have you been diagnosed with an eating disorder in the past 12 months?

Yes No

Have you ever received electroconvulsive therapy (ECT) for depression?

Yes No

Have you ever had a seizure?

Yes No

Simple childhood febrile convulsions do not count.

Have you ever had a positive test result for HIV, hepatitis B, or hepatitis C?

Yes No

In the past 6 months, have you experienced either of the following?
○ Thoughts of suicide where you had some intention of acting on them, even without a specific plan.
○ Thoughts of suicide with a specific plan and intention to act on those thoughts.

Yes to either No Prefer not to answer

Have you made a suicide attempt in the past 24 months?

Yes No Prefer not to answer

Support is available

If you are struggling or thinking about suicide, help is available right now — you do not need to be in this study to use it.

988 Suicide & Crisis Lifeline — call or text 988 (24/7, free, confidential)
Crisis Text Line — text HOME to 741741
If you are in immediate danger, call 911 or go to your nearest emergency room.

Do you have a diagnosis of recurrent Major Depressive Disorder (MDD) confirmed by a healthcare professional, with at least one prior depressive episode (not counting your current episode), and has your current episode lasted at least 6 weeks?

Yes No

Are you free from antidepressant medication, or willing to stop taking antidepressants before the study begins if your doctor agrees this is medically safe?

Yes No

To the best of your knowledge, is your BMI between 17.5 and 40 kg/m²?

Yes No Unsure

Are you willing to use a highly effective method of contraception throughout the study if this applies to you?

Yes No Not applicable

Are you willing and able to attend study visits in Austin, Texas and follow all study procedures for the full duration of the study (approximately 4 months)?

Yes No

If you are currently in formal cognitive or behavioral therapy (such as CBT) that began more than 6 months ago, are you willing to continue that therapy unchanged and not start any new therapy during the study?

Yes No Not currently in therapy

Are you willing to allow the study team to notify your primary care doctor of your participation, where this applies to you?

Yes No Not applicable

In the 24 hours before any clinic visit, you would be asked not to drink alcohol. On your clinic visit days, the study team will conduct a breath alcohol test. Are you willing to abstain from alcohol for 24 hours before each clinic visit?

Yes No

In the past 24 weeks (approximately 6 months), have you received any investigational drug or taken part in another clinical research study?

Yes No

In the past 6 months, have you regularly used any of the following substances? Select all that apply.

Alcohol (moderate to heavy use, e.g. more than 14 units per week regularly) Benzodiazepines (non-prescribed) Cannabis or cannabinoids Other recreational drugs None of the above

Are you currently using marijuana or cannabis products?

Yes No

This study does not permit any marijuana or cannabis use for the full duration of your participation (approximately 4 months). Would you be willing and able to stop using marijuana or cannabis completely before the study begins and for the entire study period?

Yes No

Are you currently using, or do you plan to use, any of the following? Select all that apply.

St John's Wort (used in the past 14 days or currently) Antiepileptic medications (e.g. gabapentin, pregabalin, phenytoin) Sedating medications (other than occasional prescribed benzodiazepines) Strong CYP3A4 inhibitors or inducers (e.g. ketoconazole, rifampicin) None of the above

Ask your doctor if you are unsure whether a medication is a CYP3A4 inhibitor or inducer.

The study medicine is taken as a once-daily capsule in the morning on an empty stomach (fasted). You would need to take it without eating beforehand each day. Are you willing and able to follow this dosing routine?

Yes No

During the study, you would also be asked to avoid grapefruit, grapefruit juice, and Seville oranges from your first visit through approximately Day 56. Are you willing to follow these dietary restrictions?

Yes No

Are you currently donating blood regularly, or have you donated more than 400 mL of blood or more than 50 mL of plasma in the past 2 months?

Yes No

This study is based in Austin, Texas. All clinic visits take place at the study site in Austin. Are you able to travel to Austin, Texas for clinic visits?

Yes No

This study involves approximately 8 clinic visits over about 4 months, plus one phone call. Some visits — particularly your first visit and visits at weeks 6 and 8 — may last several hours and will include blood draws at specific timed intervals, a heart rhythm test, questionnaires, and cognitive assessments. Would you be willing to attend this number and type of visits?

Yes No

The study team will give you a full schedule in advance so you can plan accordingly.

This study is a placebo-controlled study, which means participants are randomly assigned to receive either the investigational medicine (at one of two dose levels) or a placebo (a capsule with no active medicine). You will have approximately a 1 in 3 chance of receiving the placebo, and you will not be told which you are receiving during the study. Are you comfortable participating under these conditions?

Yes No

The study involves some blood draws at specific timed intervals during certain clinic visits (for example, before and after taking your morning dose). Are you comfortable with blood draws?

Yes No I have concerns

How did you hear about this study?

Social media (Facebook, Instagram, etc.) Online search Physician or healthcare provider referral Family or friend Community organization Flyer or poster Other

If you were referred by a healthcare provider, please note their name and practice (optional):

TARIAN-1 Major Depressive Disorder Research Study – Screening Questionnaire