Treatments for Psychogenic Nonepileptic Seizures (NES)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00159965
First received: September 8, 2005
Last updated: January 4, 2011
Last verified: August 2010
Results First Received: August 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Convulsion, Non-Epileptic
Conversion Disorder
Depression
Stress Disorders, Post-Traumatic
Interventions: Drug: sertraline
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Sertraline 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
Placebo flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES

Participant Flow:   Overall Study
    Sertraline     Placebo  
STARTED     19     19  
COMPLETED     12     14  
NOT COMPLETED     7     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sertraline 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
Placebo flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Total Total of all reporting groups

Baseline Measures
    Sertraline     Placebo     Total  
Number of Participants  
[units: participants]
  19     19     38  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     19     19     38  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38  ± 13.9     34.4  ± 12.6     36.2  ± 13.2  
Gender  
[units: participants]
     
Female     16     13     29  
Male     3     6     9  
Region of Enrollment  
[units: participants]
     
United States     19     19     38  



  Outcome Measures
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1.  Primary:   Number of Nonepileptic Seizures (NES)   [ Time Frame: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12 ]

2.  Secondary:   Beck Depression Inventory-II (BDI-II)   [ Time Frame: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12 ]

3.  Secondary:   Modified Hamilton Depression Scale (MHRS)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]

4.  Secondary:   Global Assessment of Functioning (GAF)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]

5.  Secondary:   Davidson Trauma Scale (DTS)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]

6.  Secondary:   Barratt Impulsivity Scale (BIS)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]

7.  Secondary:   Dissociative Experiences Scale (DES)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]

8.  Secondary:   Symptom Checklist 90 (SCL-90)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]

9.  Secondary:   Oxford Handicap Scale (OHS)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]

10.  Secondary:   Clinical Global Impressions - Severity (CGI-S)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]

11.  Secondary:   Clinical Global Impressions - Improvement (CGI-I)   [ Time Frame: Weeks 2, 6, 10 ]

12.  Secondary:   Family Assessment Device (FAD)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]

13.  Secondary:   Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]

14.  Secondary:   Quality of Life in Epilepsy-31 (QOLIE-31)   [ Time Frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: William_LaFrance_Jr@Brown.edu


Publications of Results:
Other Publications:

Responsible Party: W. Curt LaFrance, Jr., MD, MPH / Director of Neuropsychiatry and Behavioral Neurology, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00159965     History of Changes
Other Study ID Numbers: 5K23 NS 045902-05, 5K23NS045902
Study First Received: September 8, 2005
Results First Received: August 11, 2010
Last Updated: January 4, 2011
Health Authority: United States: Institutional Review Board