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Brain Imaging to Understand the Role of Inflammation in N-Acetyl Cysteine (NAC) Treatment of Bipolar Depression | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

Brain Imaging to Understand the Role of Inflammation in N-Acetyl Cysteine (NAC) Treatment of Bipolar Depression

Neuroinflammation as a Novel Target to Treat Bipolar Depression: A Pilot PET Study With [11C]PBR-28 and N-Acetyl Cysteine (NAC) Antidepressant Treatment

NCT03730064•Martin Lan

View on ClinicalTrials.gov

Summary

We are trying to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, we are looking at the importance of inflammation in the process. If you participate, you will have two different brain scans (MRI and PET scan). You will also have an experimental treatment for your depression named N-acetyl cysteine (NAC). The study is funded by the Columbia University Irving Institute to improve the treatment of bipolar disorder. Please contact us if you are interested in participating. Up to $600 in compensation if you are eligible and choose to participate. Up to 6 months of treatment for depression at no cost to you.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Bipolar 2 disorder and meets criteria for a major depressive episode
•Age 18-60
•Females of child-bearing potential must be willing to use an acceptable method of birth control throughout the study
•Not currently taking psychotropic medications besides those allowed in the clinical trial

Exclusion Criteria

•Failed trial or intolerable side effects of NAC
•Diagnosis of other major psychiatric disorders such as lifetime schizophrenia, schizoaffective disorder, psychotic features of bipolar disorder, current drug or alcohol abuse or recent drug or alcohol dependence
•Significant active physical illness, including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure, chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease. Any disorders with inflammation, malignancy, autoimmune or infectious etiology. Systolic blood pressure \>140 or diastolic blood pressure \> 100 Hemoglobin \<11 in females or \<13 in males
•Metal implants, pacemaker, metal prostheses, metal orthodontic appliances or shrapnel in the body
•Current, past or anticipated exposure to radiation

Locations (1)

Columbia University Medical Center

New York, New York, United States

Key Dates

Start Date

November 1, 2018

Primary Completion Date

March 1, 2021

Completion Date

March 1, 2021

Last Updated

August 5, 2021

Enrollment

ACTUAL participants

Conditions

Bipolar DisorderDepression

Interventions

N-acetyl cysteine (NAC)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Brain Imaging to Understand the Role of Inflammation in N-Acetyl Cysteine (NAC) Treatment of Bipolar Depression

Inclusion Criteria

Exclusion Criteria

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Readiness and Progress in Emotion Regulation Therapy

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

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