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

  • STATUS
    Recruiting
  • End date
    Jan 21, 2023
  • participants needed
    12
  • sponsor
    Medical University of South Carolina
Updated on 24 July 2022
brain imaging
lamotrigine
mania
lithium
divalproex sodium

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.

Details
Condition Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder
Treatment Placebo, N-Acetyl Cysteine
Clinical Study IdentifierNCT05340504
SponsorMedical University of South Carolina
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Ages 18-60 years
Meet DSM-5 criteria for bipolar I or II disorder
Able to provide informed consent and read, understand, and accurately complete assessment instruments
Willing to commit to medication treatment and follow-up assessments
Meets DSM-5 criteria for any mood episode (i.e., Major Depressive, Hypomanic, Manic), Current or In Partial Remission
Prescribed daily use of at least one FDA-approved mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, 2nd generation antipsychotic)
Willing to abstain from antioxidant supplements (e.g., coenzyme Q-10, vitamin E) for the duration of the study

Exclusion Criteria

A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
Meet DSM-5 criteria for substance use disorder (other than Tobacco Use Disorder) within the past 6 months
Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
Any history of brain injury with loss of consciousness greater than 5 minutes
Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range
Concomitant use of nitroglycerine, carbamazepine, or any other medication deemed to be hazardous if taken with N-Acetylcysteine (NAC)
Medication dose changes of ≥ 20% ≤ 2 weeks prior to testing
Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
Current suicidal or homicidal risk
Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale
Has taken NAC in the last month or experienced adverse effects/allergic reaction from it at any time
Significant claustrophobia and/or past negative experiences with MRI
Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)
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