Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

Recruiting

• Conditions: Depressive Disorder

• Registration Number: NCT05388461
• Lead Sponsor: Haukeland University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-03-13
• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	up to 8 weeks	overall cognitive function
Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at posttreatment with higher scores indicating more severe impairment	up to 8 weeks	overall subjective cognitive function, patient rated
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)	up to 8 weeks	depressive symptoms
Change of Beck depression inventory (BDI) score from pretreatment at posttreatment; BDI range 0-63, with higher scores indicating more severe depression	up to 8 weeks	depressive symptoms, patient rated

Secondary Outcome Measures

Name	Time	Method
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	6 months	overall cognitive function
Change of Subjective cognitive function score from pretreatment at posttreatment	up to 8 weeks	Likert scale
Change of Beck depression inventory (BDI) score from pretreatment at follow up, BDI range 0-63, with higher scores indicating more severe depression	6 months	depressive symptoms, patient rated
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)	6 months	depressive symptoms
Change of Patient rated improvement (PGI) score from pretreatment at follow up	6 months	Likert scale
Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment	up to 8 weeks	Likert scale
Change of Clinical Global Impression scale (CGI) from pretreatment at follow up	6 months	Likert scale
Change of Patient rated improvement (PGI) score from pretreatment at posttreatment	up to 8 weeks	Likert scale
Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up	6 months	overall subjective cognitive function, patient rated

Trial Locations

Locations (2)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway