Prefrontal Glutamatergic Modulation by NAC and MBCT for Depression in Youth
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- University of Cincinnati
- Study ID
- NCT07464886
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Mild Depression
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - 24 Years
- Healthy Volunteers
- Not accepted
Interventions
- N-acetylcysteine — DRUGN-acetylcysteine 2400 mg/d
- Mindfulness-based cognitive therapy — BEHAVIORALMindfulness-based cognitive therapy
- Placebo — DRUGPlacebo capsules
- Sham mindfulness-based intervention — BEHAVIORALSham mindfulness-based intervention
Study Details
The primary goal is to investigate to what extent changes in glutamate and glutathione modulation and functional integration between brain networks associated with emotion and attention regulation are associated with treatment response in mildly depressed youth.
Key Dates
- Start date
- Feb 26, 2026
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 160 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: NAC plus MBCTN-acetylcysteine 2400 mg daily and mindfulness-based cognitive therapy over 8 weeks
- Placebo Comparator: Placebo plus MBCTPlacebo capsules and mindfulness-based cognitive therapy over 8 weeks
- Sham Comparator: NAC plus sham MBCTN-acetylcysteine 2400 mg daily and sham mindfulness-based intervention over 8 weeks
- Other: Placebo plus sham MBCTPlacebo capsules daily and sham mindfulness-based intervention over 8 weeks
Primary Outcome Measure
Glutamate levels in the left ventrolateral prefrontal cortex (VLPFC) [ Time Frame: From baseline to week 8 ]
Central Contacts
- Fabiano Nery, MD, PhD513 558-5035
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience | Cincinnati | Ohio | 45219 |
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