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?

This trial explores how combining mindfulness-based cognitive therapy with the supplement N-acetylcysteine (NAC) might benefit young people with mild depression. Researchers aim to understand changes in brain networks related to emotion and attention. Participants will receive either NAC or a placebo, combined with either actual or sham mindfulness therapy, over eight weeks. Those who have experienced mild depression and have not recently used psychoactive medications may be eligible. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment nearing widespread availability.

Do I have to stop taking my current medications for the trial?

You need to be medication-free for at least 5 half-lives since the last use of a psychoactive medication, except for ADHD stimulants, which you can continue if the dose has been stable for over 2 months before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found N-acetylcysteine (NAC) to be safe and easy for people to handle, with no major side effects. Research has shown that NAC has been used safely in mental health treatments, including for depression. However, some studies report mixed results regarding its effectiveness in treating depression symptoms.

For mindfulness-based cognitive therapy (MBCT), studies indicate it can be delivered safely and effectively in clinical settings. MBCT has reduced symptoms of depression and helped prevent relapses without major safety concerns.

Overall, past research has shown both NAC and MBCT to be well-tolerated, with no significant safety issues reported.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for depression because they combine N-acetylcysteine (NAC) with mindfulness-based cognitive therapy (MBCT), offering a unique dual approach. NAC is an antioxidant that may help reduce oxidative stress linked to depression, which is a different mechanism compared to traditional antidepressants that typically alter brain chemicals like serotonin. Meanwhile, MBCT focuses on mindfulness techniques to change the way patients think and feel about their experiences, potentially providing a more holistic way to manage depression. This combination aims to address both the biological and psychological aspects of depression, setting it apart from standard medications.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that N-acetylcysteine (NAC) can help reduce symptoms of depression. Some studies found it improved mood in people with major depression and bipolar disorder. NAC demonstrated a small improvement in depression scores, suggesting its potential as an additional treatment. In this trial, one group of participants will receive NAC alongside mindfulness-based cognitive therapy (MBCT).

Mindfulness-based cognitive therapy (MBCT) has also proven effective in reducing depression symptoms. Studies show it helps prevent depression recurrence and improves emotional management. MBCT can be as effective as antidepressants for treating recurring depression. This trial will also test MBCT with a placebo and NAC with a sham MBCT intervention to explore how these treatments may work together to address depression in a complementary way.12678

Are You a Good Fit for This Trial?

This trial is for youth ages 15 to almost 25 with mild depression who have not recently taken psychiatric medications (except stable ADHD stimulants). Participants must not have severe mental health conditions, intellectual disability, recent substance abuse, or a history of certain neurological or allergic issues.

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

Trial Overview

The study compares N-acetylcysteine (a supplement), mindfulness-based cognitive therapy, and their placebos/sham versions in mildly depressed young people. It looks at how these treatments affect brain chemistry and emotional regulation.

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+

Citations

The Effectiveness of Mindfulness-Based Cognitive Therapy ...

There is evidence from at least nine clinical trials (n = 1258) that MBCT reduces the risk of relapse to depression when added to usual care, ...

The efficacy of mindfulness-based cognitive therapy in ...

MBCT is effective in reducing rumination and enhancing emotion regulation in individuals with depression. •. MBCT significantly improves mindfulness skills and ...

Clinical Effectiveness and Cost-Effectiveness of Supported ...

Practitioner-supported MBCT-SH for mild to moderate depression was clinically effective and cost-effective compared with currently recommended practitioner- ...

Efficacy of Mindfulness-Based Cognitive Therapy in ... - PMC

Patients receiving mindfulness-based cognitive therapy had a significantly reduced risk of depressive relapse within a 60-week follow-up period compared with ...

Mindfulness-based cognitive therapy versus treatment as ...

The primary clinical outcome was reduction in depression symptomatology at 34 weeks after randomisation, using the PHQ-9. Cost-effectiveness was evaluated in ...

Mindfulness-based cognitive therapy for the treatment ... - PMC

Mindfulness-based cognitive therapy (MBCT) appears to be a promising intervention for the prevention of relapse in major depressive disorder.

Mindfulness-Based Cognitive Therapy in Clinical Practice

The results showed that MBCT significantly lowered the risk of the relapse of major depression when compared to standard treatments like CBT. This has been ...

Mindfulness-Based Cognitive Therapy for Patients With ...

The study evaluated patients who received MBCT over 3 years and demonstrated that MBCT decreased the need for care regardless of medication changes.