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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03730064

Enrollment

Registered

2018-11-05

Start date

2018-11-01

Completion date

2021-03-01

Last updated

2021-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Depression

Keywords

Inflammation, NAC, N-acetyl cysteine

Brief 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.

Interventions

DRUGN-acetyl cysteine (NAC)

Experimental medication with N-acetyl cysteine (NAC) for six weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Montgomery Asberg Depression Rating Scale	Six weeks	Total score will be used; Ranges from 0 to 60 points; 60 is more most severe depression

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026