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CompletedNCT03730064Updated Aug 5, 2021

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

An Early Phase 1 interventional study of N-acetyl cysteine (NAC) in Bipolar Disorder and Depression, sponsored by Martin Lan. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-08-05.

Sponsored by Martin Lan · Early Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Mar 2021, 5 years 7 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bipolar Disorder
  • Depression

Keywords

  • Inflammation
  • NAC
  • N-acetyl cysteine
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 3 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Martin Lan is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Bipolar depressed

    Drug: N-acetyl cysteine (NAC)

Interventions

  • DrugN-acetyl cysteine (NAC)

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

06

What researchers measure

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

    Time frame: Six weeks

07

Study locations

1 site
  • Columbia University Medical Center
    New York, New York 10032, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03730064
Lead sponsor
Martin Lan
Responsible party
Martin Lan (Assistant Professor of Psychiatry, New York State Psychiatric Institute) — Sponsor-investigator
First posted
Nov 5, 2018
Start date
Nov 1, 2018
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021
Last update
Aug 5, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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