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

NCT ID: NCT05340504

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-13
• Study Completion Date: 2023-06-21

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.

Conditions

Bipolar Disorder; Bipolar I Disorder; Bipolar II Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A: N-Acetylcysteine, then Washout, then Placebo Oral Capsule

Group A will receive NAC 2 times a day for a total of 14 days. On Day 14 they will have a Magnetic Resonance Imaging (MRI) exam. They will then have a 14 day washout period. They will then receive Placebo Oral Capsule 2 times a day for 14 days and have another MRI exam on day 14.

Group Type: EXPERIMENTAL

N-Acetyl cysteine

Intervention Type: DRUG

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

Intervention Type: DRUG

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).

Group B: Placebo Oral Capsule, then Washout, then N-Acetylcysteine

Group A will receive Placebo Oral Capsule 2 times a day for a total of 14 days. On Day 14 they will have a Magnetic Resonance Imaging (MRI) exam. They will then have a 14 day washout period. They will then receive NAC 2 times a day for 14 days and have another MRI exam on day 14.

Group Type: EXPERIMENTAL

N-Acetyl cysteine

Intervention Type: DRUG

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

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milken Institute

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

James J. Prisciandaro

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Prisciandaro, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University Of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00117736

Identifier Type: -

Identifier Source: org_study_id