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Mucolytic Agent

N-Acetyl cysteine for Bipolar Disorder

Phase 2
Waitlist Available
Led By James Prisciandaro, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 of each experimental condition
Awards & highlights

Summary

This trial tests NAC, a medication that boosts a protective chemical in the brain, to see if it helps people with Bipolar Disorder. Participants will take NAC in random order over a short period. The study includes several visits and regular health check-ups. NAC has been studied for its potential benefits in treating symptoms of schizophrenia, bipolar disorder, and cannabis use disorder.

Eligible Conditions
  • Bipolar Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 of each experimental condition
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 of each experimental condition for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy

Side effects data

From 2024 Phase 2 trial • 13 Patients • NCT03499249
62%
GGT 400 IU/L >pre-KP value
46%
AST 400 IU/L >pre-KP value
31%
Loss of an IV
23%
Emesis with feeds
15%
Febrile illness
15%
Conjugated bilirubin 3 mg/dL >pre-KP value
8%
Tachycardia
8%
ALT 700 IU/L >pre-KP value
8%
INR >2.0
8%
Total bilirubin 5 mg/dL >pre-KP value
100%
80%
60%
40%
20%
0%
Study treatment Arm
N-Acetylcysteine Treatment

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B: Placebo Oral Capsule, then Washout, then N-AcetylcysteineExperimental Treatment2 Interventions
Group A will receive Placebo Oral Capsule 2 times a day for a total of 14 days. On Day 14 they will have a Magnetic Resonance Imaging (MRI) exam. They will then have a 14 day washout period. They will then receive NAC 2 times a day for 14 days and have another MRI exam on day 14.
Group II: Group A: N-Acetylcysteine, then Washout, then Placebo Oral CapsuleExperimental Treatment2 Interventions
Group A will receive NAC 2 times a day for a total of 14 days. On Day 14 they will have a Magnetic Resonance Imaging (MRI) exam. They will then have a 14 day washout period. They will then receive Placebo Oral Capsule 2 times a day for 14 days and have another MRI exam on day 14.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-Acetyl cysteine
2022
Completed Phase 4
~190
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
960 Previous Clinical Trials
7,399,548 Total Patients Enrolled
9 Trials studying Bipolar Disorder
244 Patients Enrolled for Bipolar Disorder
Milken InstituteOTHER
7 Previous Clinical Trials
275 Total Patients Enrolled
6 Trials studying Bipolar Disorder
269 Patients Enrolled for Bipolar Disorder
James Prisciandaro, PhDPrincipal InvestigatorMedical University of South Carolina
~4 spots leftby Sep 2025
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