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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340504
• Other study ID #: 00117736
• Status: Completed
• Phase: Phase 2
• Start date: May 13, 2022
• Est. completion date: June 21, 2023

Study information

• Verified date: July 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar I Disorder
• Bipolar II Disorder

Intervention

Drug:
• N-Acetyl cysteine
Group A and Group B will receive N-Acetylcysteine (NAC). Group A will receive NAC as their first 14 day condition and Group B will receive NAC as their second 14 day condition. Participants will take NAC for 14 days and then have a MRI exam after completing various assessments (clinical interview, questionnaires, etc).
• Placebo
Group A and Group B will receive Placebo. Group A will receive Placebo as their first 14 day condition and Group B will receive Placebo as their second 14 day condition. Participants will take Placebo Oral Capsule for 14 days and then have a MRI exam after completing various assessments (clinical interview, questionnaires, etc).

Locations

Country	Name	City	State
United States	Medical University Of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Milken Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dACC GSH levels through Proton Magnetic Resonance Spectroscopy	Brain GSH levels in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy	Day 14 of each experimental condition