Phase 2
Completed N=12
Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
Bipolar Disorder · Bipolar I Disorder · Bipolar II Disorder
Source: ClinicalTrials.gov NCT05340504 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy — 2.426; 2.207 Institutional Units
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy |
2.426; 2.207 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05340504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.