Phase 4
N=123
Anhedonia, Development, and Emotions: Phenotyping and Therapeutics
Depression · Anhedonia
Bottom Line
View on ClinicalTrials.gov: NCT05487885 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Montgomery-Asberg Depression Rating Scale (MADRS) Score — 28.9; 24.9; 21.4; 20.7 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Continuous theta burst stimulation (cTBS) (Device); Positive Affect Training (Behavioral); Ketamine Injectable Solution (Drug)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Erika Forbes
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) Score |
28.9; 24.9; 21.4; 20.7 | <0.001 sig |
| SECONDARY Snaith Hamilton Pleasure Scale (SHAPS) Score |
34.5; 34.2; 31.3; 33.3 | <0.005 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05487885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.