Trial · NCT05450822
Registered outcomes64
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 64
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Categorical effect of anti-seizure medication (ASM) on treatment outcome (Cohort II-III). | As change over time from the ASM evaluation period (after 4-7 weeks titration period) to six months, one, three and five years after for patients in cohort II-III. | 1\) Seizure-free within six months after starting ASM treatment and remained seizure-free for at least one year (last observed seizure within the six months after starting ASM treatment); 2) Seizure-free more than six months after starting ASM treatment and the seizure-free period lasts at least one year; 3) Fluctuations with both seizure-freedom and seizure-relapse; or 4) Never seizure-free for a year at the third- and fifth-year follow-up timepoint. |
| Primary | Categorical effect of a second seizure/epilepsy diagnosis for patients in Cohort I. | As change over time of epilepsy diagnosis at six months, one, three and five years after inclusion of patients in Cohort I. | The proportion of patients in Cohort I with one epileptic seizure who become diagnosed with epilepsy. |
| Secondary | Continuous treatment outcome using a seizure severity index (Cohort II-III). | As a monthly change over time from the ASM evaluation period (after 4-7 weeks titration period) to one, three and five years after for patients in cohort II-III. | Treatment outcome as percentage change in the Seizure Severity Questionnaire (SSQ). |
| Secondary | Continuous treatment outcome rating adverse events (Cohort II-III). | As a monthly change over time from baseline and one, three and five years after inclusion for patients in cohort II-III. | Treatment outcome as percentage change in the Liverpool Adverse Event Profile (LAEP). |
| Secondary | Continuous treatment outcome rating impression of change (Cohort II-III). | As a monthly change over time from the ASM evaluation period (after 4-7 weeks titration period) to one, three and five years after for patients in cohort II-III. | Treatment outcome as percentage change in in Patient's Global Impression of Change (PGIC). |
| Secondary | A continuous rating of depression diagnosis (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Percentage change in Major Depression Inventory (MDI). |
| Secondary | A continuous rating of depressive symptoms (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Percentage change in Inventory of Depressive Symptomatology (IDS-SR30). |
| Secondary | A continuous rating of specific depressive symptoms associated with neurological disease (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as a monthly change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Percentage change in the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E). |
| Secondary | Categorical outcome of psychiatric symptoms (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Psychopathology assessed by WHO International Classification of Diseases 10 (ICD-10) diagnostic classification and a semi-structured psychiatric, clinical interview. |
| Secondary | A continuous rating of symptoms of anxiety (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as a monthly change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Percentage change in the Generalized Anxiety Disorder 7-item (GAD-7). |
| Secondary | Performance in EMOTICOM Emotional Recognition Task (ERT-eyes) (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Differences between healthy controls and patients in recognizing facial expressions and emotions. |
| Secondary | Performance in Rey Auditory Verbal Learning Test (RAVLT) (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Differences between healthy controls and patients in verbal learning and memory. |
| Secondary | Performance in D-KEFS Color-Word Interference Test (Stroop) (Cohort II-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort II-III. | Differences between healthy controls and patients in executive function. |
| Secondary | Performance in D-KEFS Verbal Fluency (Fluency) (Cohort II-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort II-III. | Differences between healthy controls and patients in executive function. |
| Secondary | A continuous rating of Wechsler Adult Intelligence Scale (WAIS-IV) (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Differences between healthy controls and patients in IQ and specific index scores measured as percentage change in Wechsler Adult Intelligence Scale (WAIS-IV). |
| Secondary | Performance in Rey Complex Figure Test (RCFT) (Cohort II-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to 1, 3 and 5 years after inclusion for patients in cohort II-III. | Differences between healthy controls and patients in visio-spatial learning. |
| Secondary | Performance in Boston Naming Test (BNT) (Cohort II-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort II-III. | Differences between patient cohorts in word-retrieval. |
| Secondary | Performance in Trail Making Test A & B (Trail A & B) (Cohort II-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort II-III. | Differences between patient cohorts in psychomotor speed. |
| Secondary | A continuous rating of Quality of Life in Epilepsy (QUOLIE-31) (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to 1, 3 and 5 years after inclusion for patients in cohort I-III. | Differences between healthy controls and patients in quality of life measured as percentage change in Quality of Life in Epilepsy (QUOLIE-31). |
| Secondary | A continuous rating of Sheehans Disability Score (SDS) (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Differences between healthy controls and patients in quality of life measured as percentage change in Sheehans Disability Score (SDS). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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