Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depressive Disorder

Intervention / Treatment
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* Other: electroconvulsive therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: ECT performed on other indications than major depression. No consent to the register.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: electroconvulsive therapy|electroconvulsive therapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | depressive symptoms | 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 | overall cognitive function | 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 | depressive symptoms, patient rated | up to 8 weeks | 
| Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at posttreatment with higher scores indicating more severe impairment | overall subjective cognitive function, patient rated | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Patient rated improvement (PGI) score from pretreatment at posttreatment | Likert scale | up to 8 weeks | 
| Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment | Likert scale | up to 8 weeks | 
| Change of Subjective cognitive function score from pretreatment at posttreatment | Likert scale | 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) | depressive symptoms | 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 | overall cognitive function | 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 | depressive symptoms, patient rated | 6 months | 
| Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up | overall subjective cognitive function, patient rated | 6 months | 
| Change of Patient rated improvement (PGI) score from pretreatment at follow up | Likert scale | 6 months | 
| Change of Clinical Global Impression scale (CGI) from pretreatment at follow up | Likert scale | 6 months |