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Trial record 14 of 32 for:    CYSTEAMINE

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
Sponsor:
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: cysteamine bitartrate
Enrollment 3
Recruitment Details A total of 3 participants were recruited between June 2007 and May 2009.
Pre-assignment Details Participants with major depression were enrolled if they had previously failed to respond to at least one FDA-approved antidepressant. There are no prospective treatment or lead-in and the study was conducted open-label.
Arm/Group Title Cysteamine Bitartrate
Hide Arm/Group Description Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Reason Not Completed
medication not tolerated - nausea             1
Arm/Group Title Cysteamine Bitartrate
Hide Arm/Group Description Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
47  (15.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Montgomery-Åsberg Depression Rating Scale (MADRS)
Hide Description This scale measures depression severity. It ranges from a score of 0 to 60, with higher score indicating higher level of depression severity.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Mean MADRS score at end of treatment (LOCF) in 3 participants treated with cysteamine bitartrate.
Arm/Group Title Cysteamine Bitartrate
Hide Arm/Group Description:
Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: scale score
27  (3)
2.Secondary Outcome
Title Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I)
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cysteamine Bitartrate
Hide Arm/Group Description:
Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: scale score
4  (0)
3.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16)
Hide Description This is a self-report which measures the level of depression severity. I ranges from 0 (no illness) to 27 (severe illness).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cysteamine Bitartrate
Hide Arm/Group Description:
Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: scale score
13.3  (2.9)
4.Secondary Outcome
Title Systematic Assessment for Treatment Emergent Effects (SAFTEE)
Hide Description 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.
Time Frame weekly, for 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study participants were assessed for side effects or adverse events with the SAFTEE at each study visit over the 8 week trial.
Arm/Group Title Cysteamine Bitartrate
Hide Arm/Group Description:
Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: symptoms
24.3  (17.5)
Time Frame 8 weeks
Adverse Event Reporting Description Adverse events are recorded with the SAFTEE at each weekly visit during the 8 week study. All items reported here are endorsed with a severity greater than mild (e.g. moderate or severe) and represent a change from baseline.
 
Arm/Group Title Cysteamine Bitartrate
Hide Arm/Group Description Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
All-Cause Mortality
Cysteamine Bitartrate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cysteamine Bitartrate
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cysteamine Bitartrate
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Endocrine disorders   
hot flashes   1/3 (33.33%)  1
Gastrointestinal disorders   
Drooling   1/3 (33.33%)  1
Nausea   1/3 (33.33%)  1
Stomach discomfort   1/3 (33.33%)  1
appetite decrease   1/3 (33.33%)  1
General disorders   
Dry mouth   1/3 (33.33%)  1
Nervous system disorders   
Numbness or tingling   1/3 (33.33%)  1
Dizziness   2/3 (66.67%)  2
Headache   1/3 (33.33%)  1
word finding difficulty   1/3 (33.33%)  1
Psychiatric disorders   
apathy   1/3 (33.33%)  1
Reproductive system and breast disorders   
loss of sexual interest   1/3 (33.33%)  1
Vascular disorders   
bruising   1/3 (33.33%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. James Murrough
Organization: Mount Sinai School of Medicine
Phone: 212-241-7574
EMail: james.murrough@mssm.edu
Layout table for additonal information
Responsible Party: James Murrough, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00715559     History of Changes
Other Study ID Numbers: GCO # 07-0478
First Submitted: July 11, 2008
First Posted: July 15, 2008
Results First Submitted: April 18, 2011
Results First Posted: June 16, 2011
Last Update Posted: April 7, 2017