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PET Biomarkers in Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT01031810
Recruitment Status : Terminated (Needed PET facility closed)
First Posted : December 15, 2009
Results First Posted : September 18, 2014
Last Update Posted : September 18, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Drug: tranylcypromine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tranylcypromine Patients will receive treatment with tranylcypromine tablets taken orally on a twice daily schedule. Dosage was initially 10 mg daily and was increased weekly up to 120 mg daily.

Participant Flow:   Overall Study
    Tranylcypromine
STARTED   13 
COMPLETED   9 
NOT COMPLETED   4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tranylcypromine patients will receive treatment with tranylcypromine

Baseline Measures
   Tranylcypromine 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   13 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.3  (10.5) 
Gender 
[Units: Participants]
 
Female   8 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale Scores 17 at Baseline   [ Time Frame: Week 00 (baseline) ]

2.  Primary:   Hamilton Depression Rating Scale Scores 17 at week12   [ Time Frame: Week 12 ]

3.  Secondary:   Quick Inventory of Depression- Self Report 16   [ Time Frame: Weeks 00 ]

4.  Secondary:   Quick Inventory of Depression- Self Report 16   [ Time Frame: Week 04 ]

5.  Secondary:   Quick Inventory of Depression- Self Report 16   [ Time Frame: Week 12 ]

6.  Secondary:   Quick Inventory of Depression- Self Report 16   [ Time Frame: Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  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
Early termination leading to small numbers of subjects analyzed


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Patrick J. McGrath
Organization: New York State Psychiatric Institute
phone: (646) 774-8076
e-mail: mcgrath@nyspi.columbia.edu



Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01031810     History of Changes
Other Study ID Numbers: 6025
RC1MH088405-01 ( U.S. NIH Grant/Contract )
First Submitted: December 12, 2009
First Posted: December 15, 2009
Results First Submitted: October 8, 2013
Results First Posted: September 18, 2014
Last Update Posted: September 18, 2014