N-Acetyl cysteine for Manic Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Medical University Of South Carolina, Charleston, SC
Manic Disorder+3 More
N-Acetyl cysteine - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This research study evaluates the effects of anFDA-approved medication NAC in individuals with Bipolar Disorder. Participants in the study will will be assigned to two medication conditions and will take both NAC and a matched placebo. The order in which they take each medication will be random. Study medication will be taken for 14 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

Eligible Conditions

  • Manic Disorder
  • Bipolar I Disorder
  • Bipolar Disorder

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Day 14 of each experimental condition

Day 14
Change in dACC GSH levels through Proton Magnetic Resonance Spectroscopy

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Group B: Placebo Oral Capsule, then NAC
1 of 2
Group A: NAC, then Placebo Oral Capsule
1 of 2
Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: N-Acetyl cysteine · Has Placebo Group · Phase 2

Group B: Placebo Oral Capsule, then NACExperimental Group · 2 Interventions: Placebo, N-Acetyl cysteine · Intervention Types: Drug, Drug
Group A: NAC, then Placebo Oral CapsuleExperimental Group · 2 Interventions: Placebo, N-Acetyl cysteine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
N-Acetyl cysteine
2012
Completed Phase 4
~170

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 14 of each experimental condition
Closest Location: Medical University Of South Carolina · Charleston, SC
Photo of medical university of south carolina 1Photo of medical university of south carolina 2Photo of medical university of south carolina 3
2007First Recorded Clinical Trial
0 TrialsResearching Manic Disorder
17 CompletedClinical Trials

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
828 Previous Clinical Trials
5,371,841 Total Patients Enrolled
Milken InstituteOTHER
6 Previous Clinical Trials
240 Total Patients Enrolled
James Prisciandaro, PhDPrincipal InvestigatorMedical University of South Carolina

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of bipolar disorder.
You are prescribed a mood stabilizing medication.
You are willing to abstain from antioxidant supplements for the duration of the study.
You are able to provide informed consent and read, understand, and accurately complete assessment instruments.
You have experienced at least one episode of a major depressive, hypomanic, or manic episode in the past year.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.