Идёт набор NCT05388461

Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

— Наблюдательное Depressive Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: electroconvulsive therapy.
Кому может быть актуально: Состояния в реестре: Depressive Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Норвегия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy for Severe or Treatment Resistant Depression - Predictors of Response, Side Effects, and Relapse

Обзор

The overall aim of the current project is to assess the acute and long term outcome of ECT (both patient and clinician rated) in a non-selected patient cohort from ordinary clinical activity, and to seek out factors predicting response and remission, side effects and relapse.

Подробное описание

Patients reffered to electroconvulsive ECT are (after written consent) enroled in a research registry. Based on (clinician and patient rated) measures of depressive symptoms and overall cognitive function, the short and long-term (6 months) efficacy of ECT will be described, and factors predicting response and relapse identified.

The duration of possible cognitive impairment and factors predicting cognitive outcome will be examined.

Вмешательства

Другое electroconvulsive therapy
electroconvulsive therapy

Первичные конечные точки

Change of Montgomery and Åsberg Depression Rating Scale (MADRS) score from pretreatment at posttreatment; MADRS range 0 - 60, with higher scores indicating more severe depression) [Срок оценки: up to 8 weeks]
Change of Mini Mental State Examination (MMSE-NR) score from pretreatment at posttreatment; MMS-E range 0-30 with lower scores indicating more severe cognitive impairment [Срок оценки: up to 8 weeks]
Change of Beck depression inventory (BDI) score from pretreatment at posttreatment; BDI range 0-63, with higher scores indicating more severe depression [Срок оценки: up to 8 weeks]
Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at posttreatment with higher scores indicating more severe impairment [Срок оценки: up to 8 weeks]

Вторичные конечные точки (9)

Change of Patient rated improvement (PGI) score from pretreatment at posttreatment [Срок оценки: up to 8 weeks]
Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment [Срок оценки: up to 8 weeks]
Change of Subjective cognitive function score from pretreatment at posttreatment [Срок оценки: up to 8 weeks]
Change of Montgomery and Åsberg Depression Rating Scale (MADRS) score from pretreatment at follow up, MADRS range 0 - 60, with higher scores indicating more severe depression) [Срок оценки: 6 months]
Change of Mini Mental State Examination (MMSE-NR) score from pretreatment at follow up, MMS-E range 0-30 with lower scores indicating more severe cognitive impairment [Срок оценки: 6 months]
Change of Beck depression inventory (BDI) score from pretreatment at follow up, BDI range 0-63, with higher scores indicating more severe depression [Срок оценки: 6 months]
Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up [Срок оценки: 6 months]
Change of Patient rated improvement (PGI) score from pretreatment at follow up [Срок оценки: 6 months]
Change of Clinical Global Impression scale (CGI) from pretreatment at follow up [Срок оценки: 6 months]

Критерии участия

Критерии включения

Patients treated with ECT for major depression (F31.3-5, F32, F33) at Haukeland University Hospital or Stavanger University Hospital after 2013,
written consent to enrolment into the Regional Register for neurostimulation.