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Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder (TRD-2)

This study has been completed.
Sponsor:
Collaborator:
Pamlab, L.L.C.
Information provided by (Responsible Party):
George I. Papakostas, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00955955
First received: July 30, 2009
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
Results First Received: October 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Other: 6(S)-5-MTHF(Deplin)
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Deplin/Deplin Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
Placebo/Deplin Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
Placebo/Placebo Both tablets of study medication will be placebo during both phases of the study.

Participant Flow:   Overall Study
    Deplin/Deplin     Placebo/Deplin     Placebo/Placebo  
STARTED     19     28     28  
COMPLETED     17     28     28  
NOT COMPLETED     2     0     0  
Lost to Follow-up                 2                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Deplin/Deplin Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
Placebo/Deplin Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
Placebo/Placebo Both tablets of study medication will be placebo during both phases of the study.
Total Total of all reporting groups

Baseline Measures
    Deplin/Deplin     Placebo/Deplin     Placebo/Placebo     Total  
Number of Participants  
[units: participants]
 		  19     28     28     75  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     18     28     28     74  
>=65 years     1     0     0     1  
Age  
[units: years]
Mean ± Standard Deviation 		  49.58  ± 14.64     50.86  ± 10.58     45.39  ± 11.60     48.49  ± 12.17  
Gender  
[units: participants]
 		       
Female     14     19     20     53  
Male     5     9     8     22  
Region of Enrollment  
[units: participants]
 		       
United States     19     28     28     75  



  Outcome Measures
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1.  Primary:   The 17-item Hamilton Depression Scale (HAM-D-17)   [ Time Frame: Baseline and Day 60 ]
  Show Outcome Measure 1

2.  Secondary:   The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)   [ Time Frame: Baseline and Day 60 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. George Papakostas- Director of Treatment Resistant Depression Studies
Organization: Massachusetts General Hospital- Depression Clinical and Research Program
phone: 617-726-6697
e-mail: gpapakostas@partners.org


No publications provided by Massachusetts General Hospital

Publications automatically indexed to this study:


Responsible Party: George I. Papakostas, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00955955     History of Changes
Other Study ID Numbers: 2006P000604 (2)
Study First Received: July 30, 2009
Results First Received: October 31, 2012
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board