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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

Study Summary

This trial is testing whether NAC, an FDA-approved medication, is effective in treating bipolar disorder. Participants will take NAC and a placebo, and the order will be randomized. There will be 5 study visits and 2 MRI brain scans.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Conjugated bilirubin 3 mg/dL >pre-KP value
15%
Febrile illness
8%
INR >2.0
8%
Total bilirubin 5 mg/dL >pre-KP value
8%
Tachycardia
8%
ALT 700 IU/L >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 NACExperimental 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: NAC, 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
Placebo
1995
Completed Phase 3
~2670
N-Acetyl cysteine
2022
Completed Phase 4
~190

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
940 Previous Clinical Trials
7,396,952 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 May 2025
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