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

Primary Purpose

Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

N-Acetyl cysteine

Placebo

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Medical University Of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A: NAC, then Placebo Oral Capsule

Group B: Placebo Oral Capsule, then NAC

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change in dACC GSH levels through Proton Magnetic Resonance Spectroscopy

Brain GSH levels in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy

Secondary Outcome Measures

Full Information

NCT ID

NCT05340504

First Posted

April 15, 2022

Last Updated

July 20, 2023

Sponsor

Medical University of South Carolina

Collaborators

Milken Institute

1. Study Identification

Unique Protocol Identification Number

NCT05340504

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

May 13, 2022 (Actual)

Primary Completion Date

June 21, 2023 (Actual)

Study Completion Date

June 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

Collaborators

Milken Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

Double-blind

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A: NAC, then Placebo Oral Capsule

Arm Type

Experimental

Arm Description

Arm Title

Group B: Placebo Oral Capsule, then NAC

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

N-Acetyl cysteine

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in dACC GSH levels through Proton Magnetic Resonance Spectroscopy

Description

Brain GSH levels in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy

Time Frame

Day 14 of each experimental condition

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Prisciandaro, PhD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University Of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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