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

NCT03730064 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 7580
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Depression

Keywords

Inflammation; NAC; N-acetyl cysteine

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale

  Total score will be used; Ranges from 0 to 60 points; 60 is more most severe depression

  Six weeks

Study Arms (1)

Bipolar depressed

EXPERIMENTAL

Drug: N-acetyl cysteine (NAC)

Interventions

N-acetyl cysteine (NAC) DRUG

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

Bipolar depressed

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Martin Lan: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression; Inflammation

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: November 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)