Prefrontal Glutamatergic Modulation by NAC and MBCT for Depression in Youth

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Mild Depression

In brief

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 facts

Study ID

NCT07464886

Run by

University of Cincinnati

People needed

160

Starts

2026-02-26

Expected to finish

2030-12-01

Last updated by the study team

2026-03-11

Who can join

Age: 15 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age between 15 years, 0 months to 24 years, 11 months old;
• presenting with mild depression, defined by meeting DSM-5 criteria for a current major depressive episode, mild severity, or persistent depressive disorder, or other specified depressive disorder (depressive episode with insufficient symptoms to meet criteria for a major depressive episode);
• medication-naïve or medication free for at least 5 half-lives since the last use of a psychoactive medication, with the exception of stimulants for ADHD;
• if on ADHD stimulant medication over 2 months prior to screening, willing to maintain stimulant dose constant during the study participation;
• Tanner stage greater than or equal to III;

You may not qualify if…

• significant suicidal risk, defined by suicidal ideation of type 3, 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months, or any lifetime suicidal attempts;
• current major depressive episode, moderate or severe
• current or lifetime history of manic or hypomanic episodes, and/or diagnosis of bipolar disorder;
• current or lifetime history of psychotic disorders, and/or prior diagnosis of schizophrenia spectrum disorders;
• active or current substance use disorders in the last 3 months, except cannabis or alcohol use disorder, mild;
• diagnosis of autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorders, Tourette's syndrome
• any contraindication to MRI scanning;
• pregnancy;
• history of major neurological disorder (e.g, epilepsy), or head trauma with > 10 minutes loss of consciousness;
• intellectual disability (IQ less than or equal to 70), as determined by the Weschler Abbreviated Scale of Intelligence (WASI);
• previous participation in any mindfulness-based treatment;
• initiating psychotherapy within 2 months prior to screening, or planning to initiate psychotherapy during study participation; if on therapy, frequency and type should remain stable for 2 months prior to enrollment and during study participation;
• no current diagnosis of asthma
• history of allergic reaction to N-acetylcysteine

Where it is running

• University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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