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Trial record 12 of 12 for:    "Somatoform Disorder" | "Serotonin Agents"

Treatments for Psychogenic Nonepileptic Seizures (NES) (NES)

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ClinicalTrials.gov Identifier: NCT00159965
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : January 25, 2011
Last Update Posted : November 20, 2014
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
W. Curt LaFrance Jr., M.D., Rhode Island Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Convulsion, Non-Epileptic
Conversion Disorder
Depression
Stress Disorders, Post-Traumatic
Interventions Drug: sertraline
Drug: placebo
Enrollment 38
Recruitment Details Patients were referred to the Rhode Island Hospital (RIH) neuropsychiatry/behavioral neurology clinic between July 2002 and June 2008, after being diagnosed with psychogenic nonepileptic seizures (PNES). PNES diagnosis was established by capturing at least one of the patient’s typical PNES on video electroencephalogram (vEEG).
Pre-assignment Details  
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Period Title: Overall Study
Started 19 19
Completed 12 14
Not Completed 7 5
Arm/Group Title Sertraline Placebo Total
Hide Arm/Group Description flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
19
 100.0%
38
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
38  (13.9) 34.4  (12.6) 36.2  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
16
  84.2%
13
  68.4%
29
  76.3%
Male
3
  15.8%
6
  31.6%
9
  23.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
1.Primary Outcome
Title Number of Nonepileptic Seizures (NES)
Hide Description psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.
Time Frame bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Median (Standard Deviation)
Unit of Measure: seizures
Baseline (retrospective 2 weeks prior) 5.0  (43.5) 6.0  (12.1)
Week 2 (prospectively collected from day 1-14) 3.0  (37.7) 6.0  (8.5)
Week 4 2.0  (31.5) 5.0  (10.6)
Week 6 1.0  (31.5) 3.0  (16.4)
Week 8 1.0  (24.4) 3.0  (17.4)
Week 10 2.5  (30.7) 7.0  (12.4)
Week 12 0.0  (20.3) 6.0  (14.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments Between-group seizure change. The primary hypothesis of this pilot randomized control trial (RCT) was to assess the magnitude of seizure frequency reduction by treatment, comparing placbo to sertraline. The alternative hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Overdispersed Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio, log
Estimated Value 0.673
Confidence Interval (2-Sided) 95%
-0.051 to 1.396
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.369
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sertraline
Comments Within-group seizure change. The hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Overdispersed Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio, log
Estimated Value -0.598
Confidence Interval (2-Sided) 95%
-1.139 to -0.073
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.276
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments Within-group seizure change. The hypothesis is that patients treated with placebo will not show a significant decrease in seizures from baseline to exit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Overdispersed Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio, log
Estimated Value 0.077
Confidence Interval (2-Sided) 95%
-0.431 to 0.571
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.252
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Beck Depression Inventory-II (BDI-II)
Hide Description The BDI-II assesses depression severity from "0" (no Depression-related symptom) to "3" (severe) on each question. The highest possible score is "51", relating to the worst outcome.
Time Frame bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 16.7  (13.0) 22.1  (13.9)
Exit 11.7  (11.5) 17.0  (13.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Modified Hamilton Depression Scale (MHRS)
Hide Description The MHRS assesses the severity of Depression-related symptoms from "0" (not present) to "2", "3" or "4" (severe) on each question. The highest possible score is "72", relating to the worst outcome.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17.8  (21.0) 16.8  (8.8)
Exit 11.6  (9.0) 13.3  (8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Global Assessment of Functioning (GAF)
Hide Description This GAF rating scale ranges from 0 (worst) to 100 (best) and is used for evaluating the overall functioning of a subject during a specified time period on a continuum from psychological or psychiatric sickness to health.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 53.3  (10.3) 49.1  (7.1)
Exit 56.8  (11.0) 52.0  (7.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Davidson Trauma Scale (DTS)
Hide Description The DTS is a 17-item self-report scale measuring each Diagnostic and Stastical Manual of Mental Disorders-4th Edition (DSM-IV) symptom of post-traumatic stress disorder (PTSD) on 5-point frequency (0-not at all to 4-everyday) and severity (0-not at all distressing to 4-extremely distressing) scales. The highest possible score is 136 and relates to the worst outcome.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 52.5  (31.6) 48.1  (40.0)
Exit 40.3  (36.9) 43.4  (40.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Barratt Impulsivity Scale (BIS)
Hide Description The BIS is a 30 item self-report measure that characterizes four aspects of impulsiveness, and ranges from "rarely/ never" to "almost always" with a score of "1" to "4" possible on each question, giving a maximum possible score of 120 and minimum possible score of 30. Selected questions are reversed scored. Higher scores relate to a worse outcome.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 57.8  (16.5) 72.6  (17.8)
Exit 64.9  (13.2) 66.2  (15.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Dissociative Experiences Scale (DES)
Hide Description The DES is a 28 item self-report questionnaire designed to quantify dissociative experiences which identifies disturbances in memory, identity, cognition, derealization, depersonalization, absorption and imagination. A visual analogue scale is used ranging from 0% (“This never happens to you”) to 100% (“This always happens to you”). The score is divided by 28 items to yield a range of 0 to 100%, with a higher score relating to a higher degree of dissociation.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 21.0  (19.7) 17.4  (11.0)
Exit 8.5  (13.2) 12.1  (12.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Symptom Checklist 90 (SCL-90)
Hide Description The SCL-90 is a 90 item self-report clinical rating scale oriented toward symptomatic behavior of outpatients, assessing from "0" (not at all bothered) to "4" (extremely bothered). The highest possible overall score is 360 and relates to a worse outcome.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 84.9  (73.3) 109.4  (70.9)
Exit 78.9  (67.2) 91.4  (77.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Oxford Handicap Scale (OHS)
Hide Description The OHS is a brief clinician scored assessment of symptoms and lifestyle interference and the 6 grades of disability are based on the modified Rankin Scale, ranging from "0" (no symptoms) to "5" (severe handicap). A higher score relates to a worse outcome.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 3.1  (0.8) 3.4  (0.7)
Exit 2.3  (1.3) 2.6  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Clinical Global Impressions - Severity (CGI-S)
Hide Description The CGI-S is the first item of a two-item global rating scale, where each item is on a 7 point scale ranging from normal ("1") to among the most extremely ill patients ("7"). A higher score relates to a higher severity of illness.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.9  (0.8) 5.1  (0.6)
Exit 3.3  (1.6) 3.9  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Clinical Global Impressions - Improvement (CGI-I)
Hide Description The CGI-I is the second item of a two item global rating scale, where each item is on a 7 point scale ranging from very much improved ("1") to very much worse ("7"). A lower score represents a higher improvement.
Time Frame Weeks 2, 6, 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.9  (1.4) 3.5  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Family Assessment Device (FAD)
Hide Description The FAD is a 60 item self-report questionnaire designed to assess the six dimensions of the McMaster Model of Family Functioning, as well as overall level of family functioning through the General Functioning Scale. Each question is scored on a "1" to "4" scale, with a higher mean score relating to a worse general functioning.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: General Functioning Subscale Score
Baseline 2.0  (0.7) 2.0  (0.5)
Exit 2.0  (0.6) 2.2  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)
Hide Description The LIFE-RIFT interview is a brief semi-structured interview, which measures functional impairment, targeting four domains: work, interpersonal relations, recreation and global satisfaction. Work, recreation and global satisfaction are rated on a "1" (very good/ no impairment) to "5" (very poor/ severe impairment) scale, and interpersonal relations is rated on a "1" (very good) to "7" (variable) scale. The highest score possible is 20 and relates to a more severe impairment. The lowest possible score is 3.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 11.8  (3.6) 13.9  (3.8)
Exit 11.8  (4.8) 13.8  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Quality of Life in Epilepsy-31 (QOLIE-31)
Hide Description This is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.
Time Frame Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 48.4  (20.7) 38.2  (19.0)
Exit 56.7  (25.1) 46.9  (24.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
All-Cause Mortality
Sertraline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sertraline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sertraline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      4/19 (21.05%)    
Nervous system disorders     
tiredness/ sleepiness  [1]  1/19 (5.26%)  1 4/19 (21.05%)  4
Indicates events were collected by systematic assessment
[1]
Adverse events profile and symptoms checklist
pilot sample size; drop-outs because of some patient’s concern that they would receive the placebo, despite the equipoise that exists for NES treatment(s). Excluding patients who did not have vEEG may present a potential sampling bias.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: W. Curt LaFrance, Jr., MD, MPH
Organization: Rhode Island Hospital
Phone: 401-444-3534
Responsible Party: W. Curt LaFrance Jr., M.D., Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00159965     History of Changes
Other Study ID Numbers: 5K23NS045902-05 ( U.S. NIH Grant/Contract )
5K23NS045902 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: August 11, 2010
Results First Posted: January 25, 2011
Last Update Posted: November 20, 2014