Clinical trial NCT05340504: Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
Official title: Experimentally Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar Disorder
Bipolar I Disorder
Bipolar II Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Milken Institute
First posted: 2022-04-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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 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 complete assessment 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) for the duration of the study.

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 the results 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 (in the past 3 months)
6. Any uncontrolled medical condition that may adversely affect the conduct of the study 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 times the normal range
9. Concomitant use of nitroglycerine, carbamazepine, or any other medication deemed to be 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 adequate forms of contraception
12. Current suicidal or homicidal risk
13. Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale
14. Has taken NAC in the last month or experienced adverse effects/allergic reaction from 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)

Primary outcomes:
measure: Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy
timeFrame: Day 14 of each experimental condition
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: James Prisciandaro, PhD
role: PRINCIPAL_INVESTIGATOR
References: