Clinical trial NCT05388461: Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy
Official title: Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy for Severe or Treatment Resistant Depression - Predictors of Response, Side Effects, and Relapse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depressive Disorder
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
First posted: 2022-05-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: population based cohort from ordinary clinical activity

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: up to 8 weeks
measure: 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
timeFrame: up to 8 weeks
measure: Change of Beck depression inventory (BDI) score from pretreatment at posttreatment; BDI range 0-63, with higher scores indicating more severe depression
timeFrame: up to 8 weeks
measure: Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at posttreatment with higher scores indicating more severe impairment
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Change of Patient rated improvement (PGI) score from pretreatment at posttreatment
timeFrame: up to 8 weeks
measure: Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment
timeFrame: up to 8 weeks
measure: Change of Subjective cognitive function score from pretreatment at posttreatment
timeFrame: up to 8 weeks
measure: 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)
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Change of Beck depression inventory (BDI) score from pretreatment at follow up, BDI range 0-63, with higher scores indicating more severe depression
timeFrame: 6 months
measure: Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up
timeFrame: 6 months
measure: Change of Patient rated improvement (PGI) score from pretreatment at follow up
timeFrame: 6 months
measure: Change of Clinical Global Impression scale (CGI) from pretreatment at follow up
timeFrame: 6 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
References: