Bipolar DisorderPhase 2NCT05340504

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

A Phase 2 study testing N-Acetyl cysteine in people with Bipolar Disorder and Bipolar I Disorder, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder
What is being tested?: N-Acetyl cysteine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 13 May 2022to 21 Jun 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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

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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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University Of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

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

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
Being tested: N-Acetyl cysteine, Placebo
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N-Acetyl cysteineDrug
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).
PlaceboDrug
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).

Study groups in NCT05340504
Study group	Role	What they receive
Group A: N-Acetylcysteine, then Washout, then Placebo Oral Capsule	Experimental	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. Receives: Drug: N-Acetyl cysteine; Drug: Placebo
Group B: Placebo Oral Capsule, then Washout, then N-Acetylcysteine	Experimental	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. Receives: Drug: N-Acetyl cysteine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy
Brain GSH levels, balanced with water and CSF-corrected, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy
Measured: Day 14 of each experimental condition

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 202221 Jun 2023

First posted22 Apr 2022
Study start13 May 2022
Primary completion21 Jun 2023
Study completion21 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05340504
Sponsor's protocol ID: 00117736
Status last verified: May 2024
First submitted: 15 Apr 2022
Last updated: 26 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Experimentally Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
ClinicalTrials.gov ID: NCT05340504
Acronym / sponsor ID: 00117736
Conditions: Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: Milken Institute
Study start: 13 May 2022 (actual)
Primary completion: 21 Jun 2023 (actual)
Study completion: 21 Jun 2023 (actual)
First posted: 22 Apr 2022 (actual)
Results: Posted 26 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Group A: N-Acetylcysteine, then Washout, then Placebo Oral Capsule	Experimental	Drug: N-Acetyl cysteine, Drug: PlaceboGroup 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 B: Placebo Oral Capsule, then Washout, then N-Acetylcysteine	Experimental	Drug: N-Acetyl cysteine, Drug: PlaceboGroup 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (16 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
N-Acetyl cysteineGroup 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).	Drug	Group A: N-Acetylcysteine, then Washout, then Placebo Oral Capsule, Group B: Placebo Oral Capsule, then Washout, then N-Acetylcysteine
PlaceboGroup 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).	Drug	Group A: N-Acetylcysteine, then Washout, then Placebo Oral Capsule, Group B: Placebo Oral Capsule, then Washout, then N-Acetylcysteine

Primary outcome

Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy
Time frame: Day 14 of each experimental condition
Brain GSH levels, balanced with water and CSF-corrected, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy

Results and safety

Results posted to the registry on 26 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: N-Acetylcysteine, Washout, Then Placebo Oral Capsule	6	5
Group B: Placebo Oral Capsule, Washout, Then N-Acetylcysteine	6	6

Primary outcome: Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy

Time frame: Day 14 of each experimental condition. Mean (Standard Deviation). Unit: Institutional Units

Measure	N-Acetylcysteine n = 10	Placebo n = 10
Value	2.426 (0.341)	2.207 (0.423)

Population analysed: Overall number of participants analyzed includes participants who completed full study protocol (i.e. 2, 2-week medication trials and 1, 2-week washout period). Two participants have been removed from outcome measure data (1 - participant lost to follow up and did not complete placebo condition, 1 - participant's MRI data was unusable due to excessive head motion). Data from these 2 participants has been included in other portions of this study record (Adverse Events, Demographics, etc).

Adverse events

Time frame: Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
N-Acetylcysteine	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Placebo Oral Tablet	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Washout	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Prisciandaro, PhD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing N-Acetyl cysteine in people with Bipolar Disorder and Bipolar I Disorder, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy (time frame: Day 14 of each experimental condition). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05340504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.