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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730064
Recruitment Status : Suspended (Due to COVID-19 pandemic)
First Posted : November 5, 2018
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Martin Lan, New York State Psychiatric Institute

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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


Outcome Measures
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Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale [ Time Frame: Six weeks ]
    Total score will be used; Ranges from 0 to 60 points; 60 is more most severe depression


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730064


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Martin Lan
More Information
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Responsible Party: Martin Lan, Assistant Professor of Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03730064    
Other Study ID Numbers: 7580
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Lan, New York State Psychiatric Institute:
Inflammation
NAC
N-acetyl cysteine
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
 Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes