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

Martin Lan

Status and phase: Completed; Early Phase 1

Conditions: Bipolar Disorder; Depression

Treatments: Drug: N-acetyl cysteine (NAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03730064

7580

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Bipolar depressed

Experimental group

Treatment:

Drug: N-acetyl cysteine (NAC)