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

Sponsor

Martin Lan (Other)

Overall Status

Completed

CT.gov ID

NCT03730064

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder Depression	Drug: N-acetyl cysteine (NAC)	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Bipolar depressed

Drug: N-acetyl cysteine (NAC)

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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