Cysteamine Therapy for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title: An Open-Label Study of Cysteamine Bitartrate in Treatment-Resistant Major Depression

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine whether cysteamine bitartrate, an FDA-approved drug for a non-psychiatric condition, is safe and effective for the treatment of major depression.

Clinical Trial Description

Major depressive disorder (MDD) is a chronic, disabling illness affecting about 17% of the general population. Despite advances in treatment, about two-thirds of patients fail to respond to an initial trial of pharmacotherapy. Brain-derived neurotrophic factor (BDNF) is a neural growth-promoting polypeptide found in the central nervous system, and has been implicated in the pathophysiology and potential treatment of MDD. A multitude of studies have shown low levels of BDNF in subjects with MDD, which have normalized after treatment with an antidepressant. Traditional antidepressants such as serotonin reuptake inhibitors may increase BDNF via an indirect intracellular pathway. The current study drug, cysteamine bitartrate (Cystagon), is FDA approved for the treatment nephropathic cystinosis and has been shown to increase BNDF in neuronal tissue, and to stimulate cell growth. Cysteamine has already been investigated in humans as a potential treatment for Huntington's Disease. Given the evidence of decreased levels in major depression, and subsequent increase post-treatment with antidepressants, BDNF may play a key role in developing novel treatments for patients who have failed conventional agents. Therefore, drugs that can demonstrably increase central BDNF, such as cysteamine, may have significant potential as novel antidepressant medications. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT00715559
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Terminated
• Phase: N/A
• Start date: July 2008
• Completion date: May 2009