Status:
COMPLETED
Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Milken Institute
Conditions:
Bipolar Disorder
Bipolar I Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05340504
Start Date
May 13 2022
End Date
June 21 2023
Last Update
June 26 2024
Active Locations (1)
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1
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425