NCT07464886 · University of Cincinnati
Prefrontal Glutamatergic Modulation by NAC and MBCT for Depression in Youth
(NAC+MIND)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
N-acetylcysteine
N-acetylcysteine 2400 mg/d
BEHAVIORAL
Mindfulness-based cognitive therapy
Mindfulness-based cognitive therapy
DRUG
Placebo
Placebo capsules
BEHAVIORAL
Sham mindfulness-based intervention
Sham mindfulness-based intervention
Primary outcome measures
Glutamate levels in the left ventrolateral prefrontal cortex (VLPFC)
Time frame: From baseline to week 8
Changes in glutamate levels, measured by proton spectroscopy, in the left VLPFC following 8-week treatment with NAC and/or MBCT.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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;
- 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
- Cincinnati, Ohio
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations