Conversion Disorder, Convulsion, Non-Epileptic, Depression, Stress Disorders, Post-Traumatic
Conditions
Keywords
nonepileptic seizure, pseudoseizure, conversion disorder, psychogenic, Depression, Anxiety, Abuse, post-traumatic stress disorder, sertraline, serotonin, randomized controlled trial
Brief summary
The investigators propose that treatment of the comorbid disorders (depression, anxiety, and impulsivity) with sertraline in patients with lone psychogenic nonepileptic seizures (NES), will result in a decreased number of NES. The purpose of this study is to provide pilot testing and data to inform the future randomized controlled trial based on the hypothesis.
Detailed description
This is a pilot, prospective, single center, randomized, placebo-controlled, double-blind trial, that assesses the number of NES in patients treated with flexible dose sertraline (Zoloft). This study will provide outcomes data and the effect size necessary for a future R01, multi-center randomized control trial. Secondary objective variables include reduction in depression, anxiety, impulsivity scores, and improvement in psychosocial functioning. After being diagnosed with NES by video electroencephalogram monitoring (vEEG), up to 50 participants will be enrolled and monitored during a two week lead in period for their baseline NES and psychosocial symptoms and functioning. At week 2, they will be blindly randomized to the treatment arm with flexible dose sertraline (25 to 200mg) or to the placebo control arm. The dose will be titrated over 4 weeks up to 200mg or to dose limited by side effects. The subjects will stay on their maximum fixed dose for the next 4 weeks. At week 10, the subjects may elect to remain on the sertraline or they can taper off the medication over the final two weeks of the treatment trial. After the treatment trial, the subjects will have follow up phone calls at month 4, 8, and 12 after enrollment to assess seizure status, medication usage, and global functioning. Upon enrollment, subjects will be evaluated with a structured psychiatric and neurological exam, and with bi-weekly, 30 to 60 minute appointments where they will complete symptom and function scales. They will keep a seizure diary prospectively, to evaluate their daily seizure activity. They will be given two weeks of the medication at each visit. In the first phase of the study 12 patients were screened and 8 enrolled in an open label trial of flexible dose sertraline. In the second phase of the study, 38 patients enrolled in the pilot, randomized, placebo-controlled trial.
Interventions
DRUGsertraline
flexible dose sertraline
DRUGplacebo
flexible dose placebo
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Video electroencephalogram (vEEG) confirmed diagnosis of NES * Have at least one nonepileptic seizure per month * Comorbid diagnosis of either depression, anxiety, or post traumatic stress disorder (PTSD) * Able to complete self report symptom scales * Not receiving optimized antidepressant medication
Exclusion criteria
* Equivocal electroencephalogram (EEG) findings * Current suicidality, litigation, or self-mutilation * Using monoamine oxidase inhibitors (MAOIs), pimozide, or sumatriptan * Allergy/sensitivity to sertraline * Current alcohol/drug dependence * Serious medical illness requiring current hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Nonepileptic Seizures (NES) | bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12 | psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) | bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12 | 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. |
| Modified Hamilton Depression Scale (MHRS) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
| Davidson Trauma Scale (DTS) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
| Barratt Impulsivity Scale (BIS) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
| Dissociative Experiences Scale (DES) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
| Symptom Checklist 90 (SCL-90) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
| Global Assessment of Functioning (GAF) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
| Clinical Global Impressions - Severity (CGI-S) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
| Clinical Global Impressions - Improvement (CGI-I) | Weeks 2, 6, 10 | 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. |
| Family Assessment Device (FAD) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
| Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
| Quality of Life in Epilepsy-31 (QOLIE-31) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
| Oxford Handicap Scale (OHS) | Baseline and weeks 2, 6, 10 (total time frame of 12 weeks) | 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. |
Countries
United States
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| Placebo flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | Sertraline | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 38 Participants | 19 Participants |
| Age, Continuous | 38 years STANDARD_DEVIATION 13.9 | 36.2 years STANDARD_DEVIATION 13.2 | 34.4 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment United States | 19 participants | 38 participants | 19 participants |
| Sex: Female, Male Female | 16 Participants | 29 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 19 | 4 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Number of Nonepileptic Seizures (NES)
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
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Number of Nonepileptic Seizures (NES) | Week 4 | 2.0 seizures | Standard Deviation 31.5 |
| Sertraline | Number of Nonepileptic Seizures (NES) | Week 8 | 1.0 seizures | Standard Deviation 24.4 |
| Sertraline | Number of Nonepileptic Seizures (NES) | Week 2 (prospectively collected from day 1-14) | 3.0 seizures | Standard Deviation 37.7 |
| Sertraline | Number of Nonepileptic Seizures (NES) | Week 10 | 2.5 seizures | Standard Deviation 30.7 |
| Sertraline | Number of Nonepileptic Seizures (NES) | Week 6 | 1.0 seizures | Standard Deviation 31.5 |
| Sertraline | Number of Nonepileptic Seizures (NES) | Week 12 | 0.0 seizures | Standard Deviation 20.3 |
| Sertraline | Number of Nonepileptic Seizures (NES) | Baseline (retrospective 2 weeks prior) | 5.0 seizures | Standard Deviation 43.5 |
| Placebo | Number of Nonepileptic Seizures (NES) | Week 12 | 6.0 seizures | Standard Deviation 14 |
| Placebo | Number of Nonepileptic Seizures (NES) | Baseline (retrospective 2 weeks prior) | 6.0 seizures | Standard Deviation 12.1 |
| Placebo | Number of Nonepileptic Seizures (NES) | Week 2 (prospectively collected from day 1-14) | 6.0 seizures | Standard Deviation 8.5 |
| Placebo | Number of Nonepileptic Seizures (NES) | Week 4 | 5.0 seizures | Standard Deviation 10.6 |
| Placebo | Number of Nonepileptic Seizures (NES) | Week 6 | 3.0 seizures | Standard Deviation 16.4 |
| Placebo | Number of Nonepileptic Seizures (NES) | Week 8 | 3.0 seizures | Standard Deviation 17.4 |
| Placebo | Number of Nonepileptic Seizures (NES) | Week 10 | 7.0 seizures | Standard Deviation 12.4 |
Comparison: 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.p-value: 0.2995% CI: [-0.051, 1.396]Overdispersed Poisson Regression
Comparison: Within-group seizure change. The hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.p-value: 0.0395% CI: [-1.139, -0.073]Overdispersed Poisson Regression
Comparison: Within-group seizure change. The hypothesis is that patients treated with placebo will not show a significant decrease in seizures from baseline to exit.p-value: 0.7895% CI: [-0.431, 0.571]Overdispersed Poisson Regression
Secondary
Barratt Impulsivity Scale (BIS)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Barratt Impulsivity Scale (BIS) | Baseline | 57.8 Units on a scale | Standard Deviation 16.5 |
| Sertraline | Barratt Impulsivity Scale (BIS) | Exit | 64.9 Units on a scale | Standard Deviation 13.2 |
| Placebo | Barratt Impulsivity Scale (BIS) | Baseline | 72.6 Units on a scale | Standard Deviation 17.8 |
| Placebo | Barratt Impulsivity Scale (BIS) | Exit | 66.2 Units on a scale | Standard Deviation 15.9 |
p-value: >0.05ANCOVA
Secondary
Beck Depression Inventory-II (BDI-II)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Beck Depression Inventory-II (BDI-II) | Baseline | 16.7 Units on a scale | Standard Deviation 13 |
| Sertraline | Beck Depression Inventory-II (BDI-II) | Exit | 11.7 Units on a scale | Standard Deviation 11.5 |
| Placebo | Beck Depression Inventory-II (BDI-II) | Baseline | 22.1 Units on a scale | Standard Deviation 13.9 |
| Placebo | Beck Depression Inventory-II (BDI-II) | Exit | 17.0 Units on a scale | Standard Deviation 13.3 |
p-value: >0.05ANCOVA
Secondary
Clinical Global Impressions - Improvement (CGI-I)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Clinical Global Impressions - Improvement (CGI-I) | 2.9 Units on a scale | Standard Deviation 1.4 |
| Placebo | Clinical Global Impressions - Improvement (CGI-I) | 3.5 Units on a scale | Standard Deviation 1.6 |
p-value: >0.05ANCOVA
Secondary
Clinical Global Impressions - Severity (CGI-S)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Clinical Global Impressions - Severity (CGI-S) | Baseline | 4.9 Units on a scale | Standard Deviation 0.8 |
| Sertraline | Clinical Global Impressions - Severity (CGI-S) | Exit | 3.3 Units on a scale | Standard Deviation 1.6 |
| Placebo | Clinical Global Impressions - Severity (CGI-S) | Baseline | 5.1 Units on a scale | Standard Deviation 0.6 |
| Placebo | Clinical Global Impressions - Severity (CGI-S) | Exit | 3.9 Units on a scale | Standard Deviation 0.9 |
p-value: >0.05ANCOVA
Secondary
Davidson Trauma Scale (DTS)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Davidson Trauma Scale (DTS) | Baseline | 52.5 units on a scale | Standard Deviation 31.6 |
| Sertraline | Davidson Trauma Scale (DTS) | Exit | 40.3 units on a scale | Standard Deviation 36.9 |
| Placebo | Davidson Trauma Scale (DTS) | Baseline | 48.1 units on a scale | Standard Deviation 40 |
| Placebo | Davidson Trauma Scale (DTS) | Exit | 43.4 units on a scale | Standard Deviation 40 |
p-value: >0.05ANCOVA
Secondary
Dissociative Experiences Scale (DES)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Dissociative Experiences Scale (DES) | Baseline | 21.0 units on a scale | Standard Deviation 19.7 |
| Sertraline | Dissociative Experiences Scale (DES) | Exit | 8.5 units on a scale | Standard Deviation 13.2 |
| Placebo | Dissociative Experiences Scale (DES) | Baseline | 17.4 units on a scale | Standard Deviation 11 |
| Placebo | Dissociative Experiences Scale (DES) | Exit | 12.1 units on a scale | Standard Deviation 12.2 |
p-value: >0.05ANCOVA
Secondary
Family Assessment Device (FAD)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Family Assessment Device (FAD) | Baseline | 2.0 General Functioning Subscale Score | Standard Deviation 0.7 |
| Sertraline | Family Assessment Device (FAD) | Exit | 2.0 General Functioning Subscale Score | Standard Deviation 0.6 |
| Placebo | Family Assessment Device (FAD) | Baseline | 2.0 General Functioning Subscale Score | Standard Deviation 0.5 |
| Placebo | Family Assessment Device (FAD) | Exit | 2.2 General Functioning Subscale Score | Standard Deviation 0.5 |
p-value: >0.05ANCOVA
Secondary
Global Assessment of Functioning (GAF)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Global Assessment of Functioning (GAF) | Baseline | 53.3 Units on a scale | Standard Deviation 10.3 |
| Sertraline | Global Assessment of Functioning (GAF) | Exit | 56.8 Units on a scale | Standard Deviation 11 |
| Placebo | Global Assessment of Functioning (GAF) | Baseline | 49.1 Units on a scale | Standard Deviation 7.1 |
| Placebo | Global Assessment of Functioning (GAF) | Exit | 52.0 Units on a scale | Standard Deviation 7.9 |
p-value: >0.05ANCOVA
Secondary
Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT) | Baseline | 11.8 Units on a scale | Standard Deviation 3.6 |
| Sertraline | Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT) | Exit | 11.8 Units on a scale | Standard Deviation 4.8 |
| Placebo | Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT) | Baseline | 13.9 Units on a scale | Standard Deviation 3.8 |
| Placebo | Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT) | Exit | 13.8 Units on a scale | Standard Deviation 3.3 |
p-value: >0.05ANCOVA
Secondary
Modified Hamilton Depression Scale (MHRS)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Modified Hamilton Depression Scale (MHRS) | Baseline | 17.8 units on a scale | Standard Deviation 21 |
| Sertraline | Modified Hamilton Depression Scale (MHRS) | Exit | 11.6 units on a scale | Standard Deviation 9 |
| Placebo | Modified Hamilton Depression Scale (MHRS) | Exit | 13.3 units on a scale | Standard Deviation 8.4 |
| Placebo | Modified Hamilton Depression Scale (MHRS) | Baseline | 16.8 units on a scale | Standard Deviation 8.8 |
p-value: >0.05ANCOVA
Secondary
Oxford Handicap Scale (OHS)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Oxford Handicap Scale (OHS) | Baseline | 3.1 Units on a scale | Standard Deviation 0.8 |
| Sertraline | Oxford Handicap Scale (OHS) | Exit | 2.3 Units on a scale | Standard Deviation 1.3 |
| Placebo | Oxford Handicap Scale (OHS) | Exit | 2.6 Units on a scale | Standard Deviation 1.2 |
| Placebo | Oxford Handicap Scale (OHS) | Baseline | 3.4 Units on a scale | Standard Deviation 0.7 |
p-value: >0.05ANCOVA
Secondary
Quality of Life in Epilepsy-31 (QOLIE-31)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Quality of Life in Epilepsy-31 (QOLIE-31) | Exit | 56.7 Units on a scale | Standard Deviation 25.1 |
| Sertraline | Quality of Life in Epilepsy-31 (QOLIE-31) | Baseline | 48.4 Units on a scale | Standard Deviation 20.7 |
| Placebo | Quality of Life in Epilepsy-31 (QOLIE-31) | Baseline | 38.2 Units on a scale | Standard Deviation 19 |
| Placebo | Quality of Life in Epilepsy-31 (QOLIE-31) | Exit | 46.9 Units on a scale | Standard Deviation 24 |
p-value: >0.05ANCOVA
Secondary
Symptom Checklist 90 (SCL-90)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Symptom Checklist 90 (SCL-90) | Baseline | 84.9 Units on a scale | Standard Deviation 73.3 |
| Sertraline | Symptom Checklist 90 (SCL-90) | Exit | 78.9 Units on a scale | Standard Deviation 67.2 |
| Placebo | Symptom Checklist 90 (SCL-90) | Baseline | 109.4 Units on a scale | Standard Deviation 70.9 |
| Placebo | Symptom Checklist 90 (SCL-90) | Exit | 91.4 Units on a scale | Standard Deviation 77.2 |
p-value: >0.05ANCOVA