Back to resultsBrain Imaging to Understand the Role of Inflammation in N-Acetyl Cysteine (NAC) Treatment of Bipolar Depression
Primary Purpose
Bipolar Disorder, Depression
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
N-acetyl cysteine (NAC)
Sponsored by
About this trial
This is an interventional other trial for Bipolar Disorder focused on measuring Inflammation, NAC, N-acetyl cysteine
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
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bipolar depressed
Arm Description
Outcomes
Primary Outcome Measures
Montgomery Asberg Depression Rating Scale
Total score will be used; Ranges from 0 to 60 points; 60 is more most severe depression
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03730064
Brief Title
Brain Imaging to Understand the Role of Inflammation in N-Acetyl Cysteine (NAC) Treatment of Bipolar Depression
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martin Lan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Depression
Keywords
Inflammation, NAC, N-acetyl cysteine
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bipolar depressed
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine (NAC)
Intervention Description
Experimental medication with N-acetyl cysteine (NAC) for six weeks
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale
Description
Total score will be used; Ranges from 0 to 60 points; 60 is more most severe depression
Time Frame
Six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brain Imaging to Understand the Role of Inflammation in N-Acetyl Cysteine (NAC) Treatment of Bipolar Depression
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