Trial Outcomes & Findings for PET Biomarkers in Treatment Resistant Depression (NCT NCT01031810)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

Week 00 (baseline)

Results posted on

2014-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	13
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PET Biomarkers in Treatment Resistant Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tranylcypromine n=13 Participants patients will receive treatment with tranylcypromine
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	43.3 years STANDARD_DEVIATION 10.5 • n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	13 participants n=99 Participants

PRIMARY outcome

Timeframe: Week 00 (baseline)

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.

Outcome measures

Outcome measures
Measure	Tranylcypromine n=9 Participants patients will receive treatment with tranylcypromine Baseline Hamd17
Hamilton Depression Rating Scale Scores 17 at Baseline	23.2 units on a scale Standard Deviation 5.8

PRIMARY outcome

Timeframe: Week 12

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.

Outcome measures

Outcome measures
Measure	Tranylcypromine n=9 Participants patients will receive treatment with tranylcypromine Baseline Hamd17
Hamilton Depression Rating Scale Scores 17 at week12	11.67 Score on a scale Standard Deviation 6.29

SECONDARY outcome

Timeframe: Weeks 00

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

Outcome measures

Outcome measures
Measure	Tranylcypromine n=9 Participants patients will receive treatment with tranylcypromine Baseline Hamd17
Quick Inventory of Depression- Self Report 16	17.78 units on a scale Standard Deviation 3.03

SECONDARY outcome

Timeframe: Week 04

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

Outcome measures

Outcome measures
Measure	Tranylcypromine n=9 Participants patients will receive treatment with tranylcypromine Baseline Hamd17
Quick Inventory of Depression- Self Report 16	13.0 units on a scale Standard Deviation 6.27

SECONDARY outcome

Timeframe: Week 12

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

Outcome measures

Outcome measures
Measure	Tranylcypromine n=9 Participants patients will receive treatment with tranylcypromine Baseline Hamd17
Quick Inventory of Depression- Self Report 16	10.38 units on a scale Standard Deviation 5.04

SECONDARY outcome

Timeframe: Week 16

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

Outcome measures

Outcome measures
Measure	Tranylcypromine n=9 Participants patients will receive treatment with tranylcypromine Baseline Hamd17
Quick Inventory of Depression- Self Report 16	9.89 units on a scale Standard Deviation 5.23

Adverse Events

Tranylcypromine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tranylcypromine n=9 participants at risk patients will receive treatment with tranylcypromine
Gastrointestinal disorders Constipation	44.4% 4/9 • Number of events 4 • Adverse event data were collected weekly from baseline(week 00) to week 16.
General disorders Dizziness	44.4% 4/9 • Number of events 5 • Adverse event data were collected weekly from baseline(week 00) to week 16.

Additional Information

Dr. Patrick J. McGrath

New York State Psychiatric Institute

Phone: (646) 774-8076

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place