Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

• Sponsor: Haukeland University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05388461
• Collaborator: Helse Stavanger HF (Other)
• Enrollment: 600
• Locations: 2
• Anticipated Duration (Months): 188.6
• Patients Per Site: 300
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder	Other: electroconvulsive therapy

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Mar 13, 2013
• Anticipated Primary Completion Date: Dec 1, 2028
• Anticipated Study Completion Date: Dec 1, 2028

Outcome Measures

Primary Outcome Measures

1. Change of Montgomery and Åsberg Depression Rating Scale (MADRS) score from pretreatment at posttreatment [up to 8 weeks]

   depressive symptoms

2. Change of Mini Mental State Examination (MMSE-NR) score from pretreatment at posttreatment [up to 8 weeks]

   overall cognitive function

3. Change of Beck depression inventory (BDI) score from pretreatment at posttreatment [up to 8 weeks]

   depressive symptoms, patient rated

4. Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at posttreatment [up to 8 weeks]

   overall subjective cognitive function, patient rated

Secondary Outcome Measures

1. Change of Patient rated improvement (PGI) score from pretreatment at posttreatment [up to 8 weeks]

   Likert scale

2. Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment [up to 8 weeks]

   Likert scale

3. Change of Subjective cognitive function score from pretreatment at posttreatment [up to 8 weeks]

   Likert scale

4. Change of Montgomery and Åsberg Depression Rating Scale (MADRS) score from pretreatment at follow up [6 months]

   depressive symptoms

5. Change of Mini Mental State Examination (MMSE-NR) score from pretreatment at follow up [6 months]

   overall cognitive function

6. Change of Beck depression inventory (BDI) score from pretreatment at follow up [6 months]

   depressive symptoms, patient rated

7. Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up [6 months]

   overall subjective cognitive function, patient rated

8. Change of Patient rated improvement (PGI) score from pretreatment at follow up [6 months]

   Likert scale

9. Change of Clinical Global Impression scale (CGI) from pretreatment at follow up [6 months]

   Likert scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients treated with ECT for major depression (F31.3-5, F32, F33) at Haukeland University Hospital or Stavanger University Hospital after 2013, and who provided 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway	5021
2	Stavanger University Hospital	Stavanger		Norway

Sponsors and Collaborators

• Haukeland University Hospital
• Helse Stavanger HF

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT05388461
• Other Study ID Numbers: 2018/2541
• First Posted: May 24, 2022
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depressive Disorder

Study Results

No Results Posted as of May 24, 2022