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RecruitingPhase 3NCT07464886

Prefrontal Glutamatergic Modulation by NAC and MBCT for Depression in Youth

Prefrontal Glutamatergic Modulation by N-acetylcysteine and Mindfulness-based Cognitive Therapy for Mild Depression in Youth

Sponsor

University of Cincinnati

Enrollment

160 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Mild Depression

Summary

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.

Eligibility

Min Age: 15 YearsMax Age: 24 Years

Inclusion Criteria5

  • 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;

Exclusion Criteria14

  • 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

Interventions

DRUGN-acetylcysteine

N-acetylcysteine 2400 mg/d

BEHAVIORALMindfulness-based cognitive therapy

Mindfulness-based cognitive therapy

DRUGPlacebo

Placebo capsules

BEHAVIORALSham mindfulness-based intervention

Sham mindfulness-based intervention

Locations(1)

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, United States

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NCT07464886