160 Participants NeededMy employer runs this trial

NAC + Mindfulness-Based Cognitive Therapy for Depression

(NAC+MIND Trial)

FN
Overseen ByFabiano Nery, MD, PhD
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Cincinnati
Must be taking: ADHD stimulants
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have not taken psychoactive medication recently, except for ADHD stimulants.
I am between 15 and 24 years old.
I have been on ADHD medication for over 2 months and will keep my dose the same during the study.
See 2 more

Exclusion Criteria

Current or lifetime history of psychotic disorders, and/or prior diagnosis of schizophrenia spectrum disorders
Pregnancy
I have been diagnosed with autism, OCD, PTSD, Tourette's, or a similar developmental disorder.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive N-acetylcysteine and/or mindfulness-based cognitive therapy over 8 weeks

8 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness-based cognitive therapy
  • N-acetylcysteine

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Placebo plus sham MBCTExperimental Treatment2 Interventions
Group II: NAC plus MBCTActive Control2 Interventions
Group III: Placebo plus MBCTPlacebo Group2 Interventions
Group IV: NAC plus sham MBCTPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials
442
Recruited
639,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+