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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:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: tranylcypromine
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tranylcypromine
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 13
Completed 9
Not Completed 4
Arm/Group Title Tranylcypromine
Hide Arm/Group Description patients will receive treatment with tranylcypromine
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
43.3  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
8
  61.5%
Male
5
  38.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Hamilton Depression Rating Scale Scores 17 at Baseline
Hide Description

HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.

Scale range (0-52):

A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.

Time Frame Week 00 (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranylcypromine
Hide Arm/Group Description:
patients will receive treatment with tranylcypromine Baseline Hamd17
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
23.2  (5.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranylcypromine
Comments Compare the mean differences between baseline (week00) and week12 hamd17 summary scores
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method paired t-test 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.56
Confidence Interval (2-Sided) 95%
3.25 to 19.86
Parameter Dispersion
Type: Standard Deviation
Value: 10.81
Estimation Comments [Not Specified]
2.Primary Outcome
Title Hamilton Depression Rating Scale Scores 17 at week12
Hide Description

HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.

Scale range (0-52):

A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranylcypromine
Hide Arm/Group Description:
patients will receive treatment with tranylcypromine Baseline Hamd17
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: Score on a scale
11.67  (6.29)
3.Secondary Outcome
Title Quick Inventory of Depression- Self Report 16
Hide Description

Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit

Scale range (0-27):

Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16

Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression

Time Frame Weeks 00
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranylcypromine
Hide Arm/Group Description:

patients will receive treatment with tranylcypromine

tranylcypromine: monoamine oxidase inhibitor (MAOI) 60mg-120mg

Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.78  (3.03)
4.Secondary Outcome
Title Quick Inventory of Depression- Self Report 16
Hide Description

Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit

Scale range (0-27):

Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16

Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression

Time Frame Week 04
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranylcypromine
Hide Arm/Group Description:

patients will receive treatment with tranylcypromine

tranylcypromine: MAO-Inhibitor 60mg-120mg

Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.0  (6.27)
5.Secondary Outcome
Title Quick Inventory of Depression- Self Report 16
Hide Description

Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit

Scale range (0-27):

Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16

Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranylcypromine
Hide Arm/Group Description:

patients will receive treatment with tranylcypromine

tranylcypromine: MAO-Inhibitor 60mg-120mg

Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.38  (5.04)
6.Secondary Outcome
Title Quick Inventory of Depression- Self Report 16
Hide Description

Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit

Scale range (0-27):

Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16

Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression

Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranylcypromine
Hide Arm/Group Description:

patients will receive treatment with tranylcypromine

tranylcypromine: MAO-Inhibitor 60mg-120mg

Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.89  (5.23)
Time Frame Adverse event data were collected weekly from baseline(week 00) to week 16.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tranylcypromine
Hide Arm/Group Description patients will receive treatment with tranylcypromine
All-Cause Mortality
Tranylcypromine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tranylcypromine
Affected / at Risk (%) # Events
Total   0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tranylcypromine
Affected / at Risk (%) # Events
Total   5/9 (55.56%)    
Gastrointestinal disorders   
Constipation *  4/9 (44.44%)  4
General disorders   
Dizziness *  4/9 (44.44%)  5
*
Indicates events were collected by non-systematic assessment
Early termination leading to small numbers of subjects analyzed
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
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