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
Qualifiers
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
Treatments tested in this trial
- N-acetylcysteine
- Mindfulness-based cognitive therapy
- Placebo
- Sham mindfulness-based intervention
Treatment groups
160 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Cincinnati
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov