Trial Outcomes & Findings for Tranylcypromine Treatment of Bipolar Depression (NCT NCT01430455)
NCT ID: NCT01430455
Last Updated: 2018-03-15
Results Overview
29 Item Hamilton Rating Scale for Depression (HamD29) is the 29 item version of the most common depression rating scale. The scores represented here are the average scores at baseline and after 16 weeks of open label treatment. The scale is rated from 0-89 with higher scores representing a more depressed state.
COMPLETED
PHASE4
7 participants
Hamilton 29 score at baseline (start date of medication) and week 16
2018-03-15
Participant Flow
Participant milestones
| Measure |
Tranylcypromine
Active, open-label tranylcypromine treatment
Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Tranylcypromine
Active, open-label tranylcypromine treatment
Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Switched to follow-up phase
|
1
|
Baseline Characteristics
Tranylcypromine Treatment of Bipolar Depression
Baseline characteristics by cohort
| Measure |
Tranylcypromine
n=7 Participants
Active, open-label tranylcypromine treatment
Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 15 • n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Hamilton 29 score at baseline (start date of medication) and week 16Population: 2 patients who did not make it to week 16 (one dropped out at week 3 and one dropped out at week 9)
29 Item Hamilton Rating Scale for Depression (HamD29) is the 29 item version of the most common depression rating scale. The scores represented here are the average scores at baseline and after 16 weeks of open label treatment. The scale is rated from 0-89 with higher scores representing a more depressed state.
Outcome measures
| Measure |
Tranylcypromine
n=7 Participants
Active, open-label tranylcypromine treatment
Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
|
|---|---|
|
29 Item Hamilton Rating Scale for Depression (HamD29)
Baseline Score
|
27.0 Hamilton Depression score
Standard Error 1.4
|
|
29 Item Hamilton Rating Scale for Depression (HamD29)
Week 16 Score
|
5.8 Hamilton Depression score
Standard Error 2.1
|
Adverse Events
Tranylcypromine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tranylcypromine
n=7 participants at risk
Active, open-label tranylcypromine treatment
Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
|
|---|---|
|
Vascular disorders
Lightheadedness
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Weight gain
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
increased appetite
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Light Sensitivity
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle tension
|
14.3%
1/7 • Number of events 1
|
|
General disorders
water retention
|
14.3%
1/7 • Number of events 2
|
|
Vascular disorders
postural hypotension
|
14.3%
1/7 • Number of events 2
|
|
Nervous system disorders
insomnia
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Syncope
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Mild ataxia
|
28.6%
2/7 • Number of events 3
|
|
General disorders
Dry Mouth
|
14.3%
1/7 • Number of events 1
|
Additional Information
Jonathan W. Stewart
Depression Evaluation Service (New York State Psychiatric Institute)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place