Efficacy of Fluoxetine Against Seizure-induced Central Apneas
キーワード
概要
日付
| 最終確認済み: | 09/30/2016 |
| 最初に提出された: | 09/23/2015 |
| 提出された推定登録数: | 10/05/2015 |
| 最初の投稿: | 10/06/2015 |
| 最終更新が送信されました: | 10/03/2016 |
| 最終更新日: | 10/04/2016 |
| 実際の研究開始日: | 10/31/2010 |
| 一次完了予定日: | 11/30/2010 |
| 研究完了予定日: | 12/31/2014 |
状態または病気
介入/治療
Drug: FLUOXETINE
Drug: PLACEBO
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: FLUOXETINE 4 weeks of treatment before video-EEG monitoring | Drug: FLUOXETINE Fluoxetine 20 mg per day during 4 weeks prior to video-EEG, then continued during video-EEG.
At the end of video-EEG, and according to patient's decision, treatment was either progressively withdrawn (1 week at 10 mg per day and then 1 week at 5 mg per day), or replaced by fluoxetine 20 mg open-label. |
| Placebo Comparator: PLACEBO 1 month of treatment before EEG video. | Drug: PLACEBO Placebo 20 mg per day during 4 weeks prior to video-EEG, then continued during video-EEG.
At the end of video-EEG, and according to patient's decision, treatment was either progressively withdrawn (1 week at 10 mg per day and then 1 week at 5 mg per day), or replaced by fluoxetine 20 mg open-label. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: Patient suffering from drug-resistant focal epilepsy - Age ≥ 18 years - Patient for whom a video-EEG monitoring of their seizures was scheduled as part of a pre-surgical assessment - For women of childbearing age, a method of contraception considered effective by the investigator - Patient who have given their written informed consent - Patient accepting an interview with a psychologist and to be refered to a psychiatrist in the event that mood disorders were detected on mood scores and considered severe by the investigator and / or psychologist, leading to require psychiatric care or immediate antidepressant treatment - Patient with a social security number Exclusion Criteria: - Age < 18 years - Patient under legal protection - Pregnant or breastfeeding women - Hypersensitivity to fluoxetine or its excipients - History of other serious side effects related to an earlier prescription of fluoxetine; - Current suicidal ideation or history of suicide attempt - Manic episode - Disruption of liver enzymes considered material by the investigator using the following criteria: transaminases (ALT and AST)> 2N alkaline phosphatase (ALP)> 2N gamma glutamyl transpeptidase (GGT)> 5N (performed as part of routine monitoring of epileptic patients on antiepileptic treatment. Patients often exhibit changed deemed clinically insignificant due to the enzyme-inducing effect of these drugs) - Renal failure with creatinine clearance <30 ml / min - Acute heart disease - Antidepressant treatment - Other prohibited treatment (see detailed list in protocol). |
結果
主な結果の測定
1. Ictal/post-ictal hypoxemia [Duration of video-EEG following 4 weeks of fluoxetine treatment]
二次的な結果の測定
1. Change in mood score with BDI-II score [After four weeks of treatment as compared to baseline]
2. Change in mood score with NDDIE score [After four weeks of treatment as compared to baseline]
3. Change in seizure frequency [After four weeks of treatment as compared to baseline]
4. Change in sleep disorders score with SASDQ score [After four weeks of treatment as compared to baseline]
5. Change in sleep disorders score with EPWORTH score [After four weeks of treatment as compared to baseline]
6. Change in score of quality of life [After four weeks of treatment as compared to baseline]
