Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05388461
• Other study ID #: 2018/2541
• Status: Recruiting
• Start date: March 13, 2013
• Est. completion date: December 2028

Study information

• Verified date: September 2023
• Source: Haukeland University Hospital
• Contact: Ute Kessler, PhD
• Email: ute.kessler[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder

Intervention

Other:
• electroconvulsive therapy
electroconvulsive therapy

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Stavanger University Hospital	Stavanger

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change of Patient rated improvement (PGI) score from pretreatment at posttreatment	Likert scale	up to 8 weeks
Secondary	Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment	Likert scale	up to 8 weeks
Secondary	Change of Subjective cognitive function score from pretreatment at posttreatment	Likert scale	up to 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up	overall subjective cognitive function, patient rated	6 months
Secondary	Change of Patient rated improvement (PGI) score from pretreatment at follow up	Likert scale	6 months
Secondary	Change of Clinical Global Impression scale (CGI) from pretreatment at follow up	Likert scale	6 months