Recruiting
Phase 3

Observational Study

Sponsor:

University of Cincinnati

Code:

NCT07464886

Conditions

Mild Depression

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

Interventions

N-acetylcysteine

Mindfulness-based cognitive therapy

Placebo

Sham mindfulness-based intervention

Study Details

Brief 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.

Conditions

Mild Depression

Study ID

NCT07464886

Start date

Feb 26, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. age between 15 years, 0 months to 24 years, 11 months old;
2. 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);
3. 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;
4. if on ADHD stimulant medication over 2 months prior to screening, willing to maintain stimulant dose constant during the study participation;
5. Tanner stage greater than or equal to III;

Exclusion Criteria:

1. 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;
2. current major depressive episode, moderate or severe
3. current or lifetime history of manic or hypomanic episodes, and/or diagnosis of bipolar disorder;
4. current or lifetime history of psychotic disorders, and/or prior diagnosis of schizophrenia spectrum disorders;
5. active or current substance use disorders in the last 3 months, except cannabis or alcohol use disorder, mild;
6. diagnosis of autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorders, Tourette's syndrome
7. any contraindication to MRI scanning;
8. pregnancy;
9. history of major neurological disorder (e.g, epilepsy), or head trauma with > 10 minutes loss of consciousness;
10. intellectual disability (IQ less than or equal to 70), as determined by the Weschler Abbreviated Scale of Intelligence (WASI);
11. previous participation in any mindfulness-based treatment;
12. 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;
13. no current diagnosis of asthma
14. history of allergic reaction to N-acetylcysteine

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: NAC plus MBCT

N-acetylcysteine 2400 mg daily and mindfulness-based cognitive therapy over 8 weeks

placebo comparator: Placebo plus MBCT

Placebo capsules and mindfulness-based cognitive therapy over 8 weeks

sham comparator: NAC plus sham MBCT

N-acetylcysteine 2400 mg daily and sham mindfulness-based intervention over 8 weeks

other: Placebo plus sham MBCT

Placebo capsules daily and sham mindfulness-based intervention over 8 weeks

Interventions

N-acetylcysteine

N-acetylcysteine 2400 mg/d

Mindfulness-based cognitive therapy

Mindfulness-based cognitive therapy

Placebo

Placebo capsules

Sham mindfulness-based intervention

Sham mindfulness-based intervention

Primary outcome measure

  • Glutamate levels in the left ventrolateral prefrontal cortex (VLPFC) [ Time Frame: From baseline to week 8 ]

Central Contacts and Locations

Central contacts

Locations

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

More Information

Sponsor

University of Cincinnati

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Depression
  • adolescent
  • young adult
  • youth
  • mindfulness-based cognitive therapy
  • N-acetylcysteine
  • double-blind placebo controlled

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-03-11.