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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03730064
Other study ID # 7580
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date November 1, 2018
Est. completion date March 1, 2021

Study information

Verified date August 2021
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
N-acetyl cysteine (NAC)
Experimental medication with N-acetyl cysteine (NAC) for six weeks

Locations

Country Name City State
United States Columbia University Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Martin Lan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montgomery Asberg Depression Rating Scale Total score will be used; Ranges from 0 to 60 points; 60 is more most severe depression Six weeks
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