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Trial record 2 of 26 for:    inflammation | Bipolar Disorder

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730064
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Martin Lan, New York State Psychiatric Institute

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
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 : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


Contacts
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Contact: Martin J Lan, MD PhD 646 774 7610 martin.lan@nyspi.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Martin Lan, MD PhD         
Sponsors and Collaborators
Martin Lan

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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: January 18, 2020
Last Verified: January 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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Depressive Disorder
Bipolar Disorder
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Depression
Behavioral Symptoms
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