Prefrontal Glutamatergic Modulation by NAC and MBCT for Depression in Youth
ConditionMild Depression
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15-24
SponsorUniversity of Cincinnati
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
N-acetylcysteine
DrugN-acetylcysteine 2400 mg/d
Mindfulness-based cognitive therapy
BehavioralMindfulness-based cognitive therapy
Placebo
DrugPlacebo capsules
Sham mindfulness-based intervention
BehavioralSham mindfulness-based intervention
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: NAC plus MBCTActive comparator 2 interventions
Group B: Placebo plus MBCTPlacebo comparator 2 interventions
Group C: NAC plus sham MBCTSham comparator 2 interventions
Group D: Placebo plus sham MBCTOther 2 interventions
Trial outcomes
Primary outcomes
1
Glutamate levels in the left ventrolateral prefrontal cortex (VLPFC)
Changes in glutamate levels, measured by proton spectroscopy, in the left VLPFC following 8-week treatment with NAC and/or MBCT.
Time frame
From baseline to week 8Secondary outcomes
1
Functional connectivity (Fc) within prefrontal cortex-limbic circuits and within large-scale brain networks
Changes in Fc in the prefrontal cortex (VLPFC, ACC) and subcortical regions, and within large scale brain networks associated with emotion and attention regulation (cingulo-opercular, fronto-parietal, and default mode networks) following treatment with NAC and/or MBCT.
Time frame
From baseline to week 8Other outcomes
1
Glutathione levels in the prefrontal cortex
Changes in central biomarker of oxidative stress (glutathione levels in the left VLPFC and in the anterior cingulate cortex) following treatment with NAC and/or MBCT. Exploratory.
Time frame
From baseline to week 82
Thiobarbituric acid reactive substances (TBARS) serum levels
Changes in peripheral biomarker of oxidative stress (TBARS serum levels) following treatment with NAC and/or MBCT
Time frame
From baseline to week 83
Malondialdehyde (MDA) serum levels
Changes in peripheral marker of oxidative stress (MDA serum levels) following treatment with NAC and/or MBCT
Time frame
From baseline to week 84
High-sensitivity C-reactive protein (hs-CRP) serum levels
Changes in peripheral biomarker of inflammation (hs-CRP serum levels) following treatment with NAC and/or MBCT
Time frame
From baseline to week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cincinnati
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov