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Mucolytic Agent

Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine 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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14 of each experimental condition

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

Tachycardia

ALT 700 IU/L >pre-KP value

INR >2.0

Total bilirubin 5 mg/dL >pre-KP value

100%

80%

60%

40%

20%

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