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

NCT ID: NCT03730064

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2021-03-01

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.

Conditions

Bipolar Disorder; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Bipolar depressed

Group Type: EXPERIMENTAL

N-acetyl cysteine (NAC)

Intervention Type: DRUG

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

Interventions

N-acetyl cysteine (NAC)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martin Lan

OTHER

Sponsor Role: lead

Responsible Party

Martin Lan

Assistant Professor of Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

7580

Identifier Type: -

Identifier Source: org_study_id