NCT05340504

Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder

Experimentally Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder
• Bipolar I Disorder
• Bipolar II Disorder

Interventions

Type	Name	Description
DRUG	N-Acetyl cysteine	Group A and Group B will receive N-Acetylcysteine (NAC). Group A will receive NAC as their first 14 day condition and Group B will receive NAC as their second 14 day condition. Participants will take NAC for 14 days and then have a MRI exam after completing various assessments (clinical interview, questionnaires, etc).
DRUG	Placebo	Group A and Group B will receive Placebo. Group A will receive Placebo as their first 14 day condition and Group B will receive Placebo as their second 14 day condition. Participants will take Placebo Oral Capsule for 14 days and then have a MRI exam after completing various assessments (clinical interview, questionnaires, etc).

Timeline

• Start date: 2022-05-13
• Primary completion: 2023-06-21
• Completion: 2023-06-21
• First posted: 2022-04-22
• Last updated: 2024-06-26
• Results posted: 2024-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study