Trial Outcomes & Findings for Study to Treat Major Depressive Disorder (MDD) With a New Medication (NCT NCT02149836)
NCT ID: NCT02149836
Last Updated: 2019-04-16
Results Overview
The Montgomery-Asberg Depression Rating Scale (29) is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points. The MADRS is specifically designed to detect changes in depression severity in the context of a medication treatment trial.
COMPLETED
PHASE2
18 participants
baseline and after end of treatment (10 weeks)
2019-04-16
Participant Flow
Participant milestones
| Measure |
Ezogabine
Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ezogabine
Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study to Treat Major Depressive Disorder (MDD) With a New Medication
Baseline characteristics by cohort
| Measure |
Ezogabine
n=18 Participants
Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
|
|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
MADRS
|
29.50 units on a scale
STANDARD_DEVIATION 4.93 • n=5 Participants
|
|
QIDS
|
13.78 units on a scale
STANDARD_DEVIATION 3.19 • n=5 Participants
|
|
SHAPS
|
34.28 units on a scale
STANDARD_DEVIATION 5.45 • n=5 Participants
|
|
TEPS-CON
|
21.33 units on a scale
STANDARD_DEVIATION 8.39 • n=5 Participants
|
|
TEPS ANT
|
29.67 units on a scale
STANDARD_DEVIATION 4.22 • n=5 Participants
|
|
CGI-S
|
4.22 units on a scale
STANDARD_DEVIATION 0.43 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and after end of treatment (10 weeks)Population: 1 participant withdrew before end of study
The Montgomery-Asberg Depression Rating Scale (29) is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points. The MADRS is specifically designed to detect changes in depression severity in the context of a medication treatment trial.
Outcome measures
| Measure |
Ezogabine
n=18 Participants
Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
|
|---|---|
|
Montgomery-Asberg Depression Rating Scale Comparison to Baseline
Baseline
|
29.50 units on a scale
Standard Deviation 4.93
|
|
Montgomery-Asberg Depression Rating Scale Comparison to Baseline
10 weeks
|
15.83 units on a scale
Standard Deviation 7.85
|
SECONDARY outcome
Timeframe: 8 weeksNumber of symptom events as reported by the patient in a self-report measure. PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other)
Outcome measures
| Measure |
Ezogabine
n=17 Participants
Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
|
|---|---|
|
Patient Rated Inventory of Side Effects (PRISE)
|
105 events
|
SECONDARY outcome
Timeframe: 8 weeksThe Columbia-Suicide Severity Rating Scale (C-SSRS) is a comprehensive, semi-structured interview measure that uniquely measures the full spectrum of suicidality including passive and active suicidal ideation, suicidal intent as well as suicidal behaviors. Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).
Outcome measures
| Measure |
Ezogabine
n=17 Participants
Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
|
|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
|
0.278 units on a scale
Standard Deviation 0.958
|
SECONDARY outcome
Timeframe: baseline and post treatment (8 weeks)Functional MRI of reward processing: The primary neuroimaging endpoint is the degree of change observed in the reward system in the brain. Although it was an outcome measure, the data format is a set of 4-dimensional statistical maps and not reported in raw data. Mean changes in activation of the ventral tegmental area (VTA) or ventral striatum (VS) in response to reward cue to reward receipt, and VTA mean change in beta weight in response to reward cue at 8 weeks as compared to baseline. The Z-score indicates the number of standard deviations away from a reference population in the same age range. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Outcome measures
| Measure |
Ezogabine
n=18 Participants
Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
|
|---|---|
|
Changes in Reward System Activation After Treatment With Ezogabine
VS in response to reward cue
|
-0.031 z-score
Standard Deviation 0.40
|
|
Changes in Reward System Activation After Treatment With Ezogabine
VTA in response to reward cue
|
-0.043 z-score
Standard Deviation 0.55
|
|
Changes in Reward System Activation After Treatment With Ezogabine
VTA in response to reward receipt
|
-0.021 z-score
Standard Deviation 0.32
|
|
Changes in Reward System Activation After Treatment With Ezogabine
VS in response to reward receipt
|
0.013 z-score
Standard Deviation 0.23
|
Adverse Events
Ezogabine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ezogabine
n=18 participants at risk
Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
|
|---|---|
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Nervous system disorders
Dizziness
|
44.4%
8/18
|
|
Nervous system disorders
Headache
|
11.1%
2/18
|
|
Nervous system disorders
Somnolence
|
5.6%
1/18
|
|
Nervous system disorders
Confusional State
|
16.7%
3/18
|
|
Nervous system disorders
Disturbance in attention
|
5.6%
1/18
|
|
Psychiatric disorders
Illusion
|
5.6%
1/18
|
|
Psychiatric disorders
Delayed orgasm
|
5.6%
1/18
|
|
Psychiatric disorders
Erectile Dysfunction
|
5.6%
1/18
|
|
Psychiatric disorders
Nausea
|
5.6%
1/18
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18
|
|
Gastrointestinal disorders
Dry Mouth
|
5.6%
1/18
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
5.6%
1/18
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.6%
1/18
|
Additional Information
Dr. James W. Murrough
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place