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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
15 Years to 24 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators have a well-established record of conducting intervention studies integrating magnetic resonance spectroscopy (1H-MRS) and resting state functional magnetic resonance imaging (rs-fMRI) to study the neurophysiology of mood disorders."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at NAC (N-acetylcysteine) and mindfulness-based cognitive therapy for young people with mild depression. It studies whether changes in brain chemicals and connections involved in feelings and attention are linked to how well treatment works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 15 years to 24 years and 11 months old.
  • Have mild depression that meets one of the study’s listed diagnoses.
  • Have never taken medicine that affects mood or thinking, or have stopped it for at least 5 half-lives—the time needed for most of it to leave your body. ADHD stimulants are an exception.
  • If taking ADHD stimulant medicine for more than 2 months before screening, agree to keep the same dose during the study.
  • Have reached at least stage 3 of puberty, based on the Tanner scale.

Who can't join

  • Have significant suicide risk in the past 3 months or any past suicide attempt.
  • Have moderate or severe major depression; any past or current mania or hypomania (unusually high mood and energy); bipolar disorder; or a disorder involving loss of touch with reality, such as schizophrenia.
  • Have had a substance use disorder in the past 3 months, except a mild alcohol or cannabis use disorder.
  • Have autism, pervasive developmental disorder, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), or Tourette’s syndrome.
  • Cannot safely have an MRI scan, are pregnant, or have had an allergic reaction to NAC.
  • Have a major brain or nerve disorder, such as epilepsy; a head injury that caused more than 10 minutes of unconsciousness; or an intellectual disability with an IQ of 70 or below.
  • Have had mindfulness-based treatment before, started talk therapy within 2 months before screening, or plan to start during the study. Any ongoing therapy must stay the same in type and frequency for 2 months before enrollment and during the study.
  • The listing says “no current diagnosis of asthma” under exclusions. Ask the study team to explain this rule.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

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