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

August 3, 2021 updated by: Martin Lan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bipolar depressed
Drug: N-acetyl cysteine (NAC)
Experimental medication with N-acetyl cysteine (NAC) for six weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin Lan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (Actual)

November 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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