CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
N-Acetyl cysteine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05340504
NCT05340504Phase 2Completed

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

Medical University of South Carolina·interventional·Posted Apr 22, 2022·Updated Jun 26, 2024

In Brief

A Phase 2 clinical trial evaluating N-Acetyl cysteine and Placebo for Bipolar Disorder and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMilken Institute

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedApr 22, 2022
Enrollment StartMay 13, 2022
Primary CompletionJun 21, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.2 years ago

Interventions

N-Acetyl cysteinedrug

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).

Placebodrug

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).