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Trial record 45 of 1328 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Change

Study to Treat Major Depressive Disorder (MDD) With a New Medication

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ClinicalTrials.gov Identifier: NCT02149836
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Depression
Intervention Drug: ezogabine
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ezogabine
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 18
Completed 17
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Ezogabine
Hide Arm/Group Description 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 Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
51.1  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
13
  72.2%
Male
5
  27.8%
MADRS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants
29.50  (4.93)
[1]
Measure Description: The Montgomery-Asberg Depression Rating Scale (MADRS) has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
QIDS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants
13.78  (3.19)
[1]
Measure Description: Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) score - 9-item is rated 0 to 3, with the total score range from 0 (no depression) - 27 (severe depression).
SHAPS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants
34.28  (5.45)
[1]
Measure Description: the Snaith-Hamilton pleasure scale - 14-item questionnaire commonly used to assess anhedonia. A total score can be derived by summing the responses to each item. Items answered with “strongly agree”, or higher pleasure, are coded as “1”, while a “strongly disagree”, or less pleasure, response was assigned a score of “4.” Total scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia.
TEPS-CON   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants
21.33  (8.39)
[1]
Measure Description: Temporal Experience of Pleasure Scale (TEPS) - The TEPS is composed of 18-items rated on a likert-type scale ranging from 1 (Very False for me) to 6 (Very True for me), and yields two subscales measuring Anticipatory (TEPS-ANT) and Consummatory (TEPS-CON) pleasure. TEPS-CON full scale is from 9-54. Lower scores indicate greater levels of anhedonia.
TEPS ANT   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants
29.67  (4.22)
[1]
Measure Description: Temporal Experience of Pleasure Scale (TEPS) - The TEPS is composed of 18-items rated on a likert-type scale ranging from 1 (Very False for me) to 6 (Very True for me), and yields two subscales measuring Anticipatory (TEPS-ANT) and Consummatory (TEPS-CON) pleasure. TEPS-ANT full scale is from 9-54. Lower scores indicate greater levels of anhedonia.
CGI-S   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants
4.22  (0.43)
[1]
Measure Description: The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale Comparison to Baseline
Hide Description 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.
Time Frame baseline and after end of treatment (10 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant withdrew before end of study
Arm/Group Title Ezogabine
Hide Arm/Group Description:
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 Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants
29.50  (4.93)
10 weeks Number Analyzed 17 participants
15.83  (7.85)
2.Secondary Outcome
Title Patient Rated Inventory of Side Effects (PRISE)
Hide Description Number 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)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ezogabine
Hide Arm/Group Description:
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 Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: events
105
3.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The 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).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ezogabine
Hide Arm/Group Description:
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 Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.278  (0.958)
4.Secondary Outcome
Title Changes in Reward System Activation After Treatment With Ezogabine
Hide Description 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.
Time Frame baseline and post treatment (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ezogabine
Hide Arm/Group Description:
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 Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: z-score
VTA in response to reward cue -0.043  (0.55)
VTA in response to reward receipt -0.021  (0.32)
VS in response to reward cue -0.031  (0.40)
VS in response to reward receipt 0.013  (0.23)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ezogabine
Hide Arm/Group Description 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.
All-Cause Mortality
Ezogabine
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ezogabine
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ezogabine
Affected / at Risk (%)
Total   15/18 (83.33%) 
Blood and lymphatic system disorders   
Neutropenia  1/18 (5.56%) 
Gastrointestinal disorders   
Flatulence  1/18 (5.56%) 
Dry Mouth  1/18 (5.56%) 
Constipation  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders   
Joint Stiffness  1/18 (5.56%) 
Nervous system disorders   
Dizziness  8/18 (44.44%) 
Headache  2/18 (11.11%) 
Somnolence  1/18 (5.56%) 
Confusional State  3/18 (16.67%) 
Disturbance in attention  1/18 (5.56%) 
Psychiatric disorders   
Illusion  1/18 (5.56%) 
Delayed orgasm  1/18 (5.56%) 
Erectile Dysfunction  1/18 (5.56%) 
Nausea  1/18 (5.56%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. James W. Murrough
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-6539
EMail: james.murrough@mssm.edu
Layout table for additonal information
Responsible Party: James Murrough, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02149836     History of Changes
Other Study ID Numbers: GCO 14-0597
First Submitted: May 22, 2014
First Posted: May 29, 2014
Results First Submitted: January 9, 2018
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019