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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730064
• Other study ID #: 7580
• Status: Completed
• Phase: Early Phase 1
• Start date: November 1, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: August 2021
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Martin Lan

Country where clinical trial is conducted

United States, 

Outcome

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