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

Last updated: May 30, 2024
Sponsor: Medical University of South Carolina
Overall Status: Completed

Phase

2

Condition

Bipolar Disorder

Mood Disorders

Treatment

Placebo

N-Acetyl cysteine

Clinical Study ID

NCT05340504
00117736
  • Ages 18-60
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ages 18-60 years

  2. Meet DSM-5 criteria for bipolar I or II disorder

  3. Able to provide informed consent and read, understand, and accurately completeassessment instruments

  4. Willing to commit to medication treatment and follow-up assessments

  5. Meets DSM-5 criteria for any mood episode (i.e., Major Depressive, Hypomanic,Manic), Current or In Partial Remission

  6. Prescribed daily use of at least one FDA-approved mood stabilizing medication (i.e.,lithium, divalproex sodium, lamotrigine, 2nd generation antipsychotic)

  7. Willing to abstain from antioxidant supplements (e.g., coenzyme Q-10, vitamin E) forthe duration of the study.

Exclusion

Exclusion Criteria:

  1. A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)

  2. Meet DSM-5 criteria for substance use disorder (other than Tobacco Use Disorder)within the past 6 months.

  3. Any uncontrolled neurological condition (e.g., epilepsy) that could confound theresults of the study

  4. Any history of brain injury with loss of consciousness greater than 5 minutes

  5. Any history of mental retardation, dementia, or recent electroconvulsive therapy (inthe past 3 months)

  6. Any uncontrolled medical condition that may adversely affect the conduct of thestudy or jeopardize the safety of the participant

  7. Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range

  8. Renal insufficiency as indicated by plasma levels of creatinine greater than 2 timesthe normal range

  9. Concomitant use of nitroglycerine, carbamazepine, or any other medication deemed tobe hazardous if taken with N-Acetylcysteine (NAC).

  10. Medication dose changes of ≥ 20% ≤ 2 weeks prior to testing

  11. Women of childbearing potential who are pregnant, lactating, or refuse adequateforms of contraception

  12. Current suicidal or homicidal risk

  13. Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale orgreater than 25 on the Young Mania Rating Scale

  14. Has taken NAC in the last month or experienced adverse effects/allergic reactionfrom it at any time

  15. Significant claustrophobia and/or past negative experiences with MRI

  16. Presence of non-MRI safe materials in the body (e.g., ferrous metal implants,pacemaker)

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 13, 2022
Estimated Completion Date:
June 21, 2023

Connect with a study center

  • Medical University Of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

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