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NCT05340504 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 2
Development phase
12
Enrollment target

NCT05340504: Completed Phase 2 study, sponsored by Medical University of South Carolina.

NCT05340504 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05340504, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 2
Development phase
12 participants
Enrollment target

Study 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.

Primary Outcome

Brain GSH levels, balanced with water and CSF-corrected, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy

Interventions

  • DRUG Placebo
  • DRUG N-Acetyl cysteine

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2022-05-13
Est. Completion 2023-06-21
Phase Phase 2

What the finished NCT05340504 record still lists

NCT05340504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05340504 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05340504 about?

NCT05340504 is a clinical study titled "Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder". 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. Stu...

What is the current status of trial NCT05340504?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2022-05-13. Estimated completion is 2023-06-21.

What interventions are being tested in trial NCT05340504?

The interventions under investigation include: Placebo (DRUG), N-Acetyl cysteine (DRUG).

Who is sponsoring clinical trial NCT05340504?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05340504's enrollment target sits among peer trials

12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05340504, the US trial registry maintained by the National Library of Medicine. NCT05340504 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.