Cysteamine Therapy for Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT00715559|
Recruitment Status : Terminated (Change in resources available for study procedures.)
First Posted : July 15, 2008
Results First Posted : June 16, 2011
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: cysteamine bitartrate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study of Cysteamine Bitartrate in Treatment-Resistant Major Depression|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Experimental: cysteamine bitartrate
Participants received cysteamine bitartrate by mouth up to 300 mg three times daily.
Drug: cysteamine bitartrate
All enrolled participants will begin open treatment with cysteamine on the first visit of the experimental period (after screening, medical clearance and medication washout period if necessary). The dosing schedule is a flexible regimen starting at 150 mg PO three times daily. After one week, patients without intolerable side effects will increase the dose to 300 mg three times daily. The titration schedule will continue up to a maximum of 1800 mg a day. In case of adverse events, the investigator may decrease the dose by 150 mg daily.
- Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]This scale measures depression severity. It ranges from a score of 0 to 60, with higher score indicating higher level of depression severity.
- Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I) [ Time Frame: 8 weeks ]This set of scales measures "global" improvement in a patient's level of symptoms, without reference to a particular condition (ie depression). GCI-S is a measure of severity, which ranges from 0 (not ill) to 7 (severely ill). CGI-I is a measure of change, with a score of 4 indicating no change, 1 indicating very much improved and 7 indicating very much worse.
- Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) [ Time Frame: 8 weeks ]This is a self-report which measures the level of depression severity. I ranges from 0 (no illness) to 27 (severe illness).
- Systematic Assessment for Treatment Emergent Effects (SAFTEE) [ Time Frame: weekly, for 8 weeks ]The SAFTEE is used to measure somatic and other symptoms which may arise during the course of a clinical trial. This is a non-quantitative instrument that does not yield a numeric score. Instead, it provides study subjects the opportunity to check off symptoms listed on a checklist and indicate if the severity of the symptoms is "mild" "moderate" or "severe." The reported values represent symptoms that were indicated at any point during the 8 week trial at a level of "moderate" or "severe" that also represented a change from a baseline-line pre-intervention SAFTEE assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715559
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||James Murrough, MD||Icahn School of Medicine at Mount Sinai|