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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bipolar Disorder, Depression

Intervention / Treatment
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* Drug: N-acetyl cysteine (NAC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, NAC, N-acetyl cysteine