Anhedonia, Development, and Emotions: Phenotyping and Therapeutics (NCT05487885) | Clinical Trial Compass
CompletedPhase 4
Anhedonia, Development, and Emotions: Phenotyping and Therapeutics
United States123 participantsStarted 2022-07-22
Plain-language summary
The goal of the ADEPT Study is to understand anhedonia in young people and how it changes based on treatments targeting the brain circuit underlying it. Anhedonia is a challenging mental health symptom that involves difficulty with motivation to experience pleasant events. This study could help develop treatments for people whose depression does not improve with traditional treatments.
The ADEPT Study includes two phases. In Phase 1, participants are asked to go through a series of activities to measure anhedonia, including MRI scans, blood draws, behavioral tasks, clinical interviews, questionnaires, and app-based assessments of experiences and behaviors. Phase 2 involves therapeutic activities, such as transcranial magnetic stimulation (TMS), positive affect training, and, for some people, ketamine administration. If the participant qualifies and is interested, they may choose to do Phase 2 activities in addition to Phase 1.
Who can participate
Age range
15 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Phase 1 (all participants)
* Current DSM-5 depressive disorder
* Severity ≥ 12 on MADRS
* Moderate-severe anhedonia (75% of sample) or low anhedonia (25% of sample)
Phase 2 (for participants in TBS and ketamine phase, in addition to above)
• ≥ 1 failed antidepressant trial (for qualification for Phase 2 of study and definition of non-response to TMS in order to be eligible for ketamine) = Treatment for at least 6 weeks with an antidepressant medication reaching recommended dosage for adults for at least 3 weeks of the treatment (e.g., 20 mg fluoxetine)
Exclusion Criteria:
Phase 1 (all participants)
* Lifetime psychosis, bipolar disorder, or developmental disorder
* Serious, unstable neurological disorder (e.g., seizure disorder)
* Brain injury with loss of consciousness
* Moderate-severe substance use disorder, past 6 mos.
* MRI contraindications (e.g., metal in body)
Phase 2 (for participants in TBS and ketamine phase, in addition to above)
* Serious, unstable respiratory or cardiovascular illness
* Pre-TBS: Alcohol binge in past week or \> 3 drinks/day in past 3 days
* Pre-ketamine: use of MAOIs in past 2 weeks
* Pregnancy
* High blood pressure
* Current illicit stimulant use
* Lifetime recreational ketamine or PCP use
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.