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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
932 Previous Clinical Trials
7,394,378 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the application process for this research project still ongoing?

"Correct. According to clinicaltrials.gov, this medical research is currently enrolling patients; the trial was launched on May 13th 2022 and updated lastly on July 6th of that same year. The experiment requires 12 volunteers from a single site."

Answered by AI

Is it feasible to join this clinical trial?

"This clinical trial is accepting a cohort of twelve individuals between the ages 18 and 60 that have been diagnosed with manic disorder. In order to be considered, patients must meet all DSM-5 criteria for bipolar I or II disorder; they should also be taking at least one FDA approved mood stabilizing medication (e.g., lithium or lamotrigine) while abstaining from antioxidant supplements during the course of the study. Furthermore, participants need to demonstrate capacity to provide informed consent and comprehend assessment instruments related to any current/past mood episodes (i.e., Major Depressive Episode, Hypomanic Episode)."

Answered by AI

What is the current enrollment size for this medical research?

"Affirmative. According to the clinicaltrials.gov website, this medical trial is actively seeking volunteers after being initially posted on May 13th 2022 and updated as recently as July 6th 2022. 12 patients need to be enrolled from one location for successful completion of the study."

Answered by AI

What potential hazards are associated with N-Acetyl cysteine usage?

"We have allocated N-Acetyl cysteine a score of 2 due to the presence of limited clinical data supporting its safety, but no evidence suggesting efficacy at this stage."

Answered by AI

Is someone over the age of 40 qualified to partake in this exploration?

"As per the requirements of this clinical trial, participants must be between 18 and 60 years old in order to qualify."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
James J. Prisciandaro 2022. "Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05340504.
~4 spots leftby Apr 2025
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