Electroconvulsive Therapy (ECT) for Elderly Patients With... | NCT01559324

Studies
Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

NCT01559324

Sponsor

Diakonhjemmet Hospital

Status

Completed

Last Update Posted

Jul 9, 2015Estimated

Enrollment

92Actual

Phase

Phase 4

Conditions

Major Depression

Interventions

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jul 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Mar 19, 2012

First Submission Date that Met QC Criteria

Mar 20, 2012

First Posted Date

Mar 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2015

Last Update Posted Date

Jul 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gro Strømnes Dybedal, Ph.D.Student and Clinical Neuropsychologist, Diakonhjemmet HospitalPrincipal Investigator

Lead Sponsor

Diakonhjemmet HospitalOTHER

Collaborators

Name	Class
MD Tor Magne Bjølseth	UNKNOWN
MD Torfinn Lødøen Gaarden	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

ECT (electroconvulsive therapy) is mostly given to patients between the age of 60 - 85 years. There is limited evidence on the efficacy and cognitive side-effects of right unilateral (RU) and bifrontal (BF) electrode positions, the placements that are considered safe for the elderly. As far as the investigators know no randomized controlled trials (RCTs) have yet been published describing this population treated with BF or RU ECT. Non-demented depressed patients will be randomized to either method (n = 2x36). Symptom intensity, global cognitive function and biomarkers will be related to 20 healthy comparators. Testing, evaluation of depression and blood-tests are done before ECT-treatment, after a series of 6-16 ECT and 3 months after terminated ECT-treatment.

Detailed Description

Patients are assessed with Mini Mental Status Examination. Postictal reorientation time is measured. There is also a weekly rating of depression depth during the series. After the 6th ECT; Mini Mental Status Examination For a subgroup of patients; extensive blood-test samples are taken on the day of the 6th ECT.

Some of the patients receive continuation-ECT once monthly after the series. In these months patients receive treatment as usual (naturalistic observation).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bifrontal ECT (BF)	Experimental	Formula-based low dose BF ECT	Device: ECT
Right unilateral ECT (RU)	Experimental	Formula-based high-dose RU ECT	Device: ECT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECT	Device	Bifrontal ECT, low dosage	Bifrontal ECT (BF)
ECT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depression	Hamilton depression Scale 17 items (HAM-D-17), Montgomery Åsberg Depression Rating Scale (MADRS)	5 months

Secondary Outcomes

Measure	Description	Time Frame
Cognitive function		5 months
Blood-tests	Cytokines, complement factors, BDNF, S-100-beta among others	5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major depression, either unipolar or bipolar.
Competent to give informed consent.
Passing a thorough physical examination

Exclusion Criteria:

Previous ECT non - response
ECT given during last 6 months
Ongoing substance abuse
Rapid cycling bipolar or schizoaffective disorder
Parkinsons disease
Cognitive impairment (MMSE < 24/30)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Tanum, Dr.Med.	University Hospital, Akershus	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diakonhjemmet Hospital, Department of Old Age Psychiatry		Oslo		0854	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14533122	Background	van der Wurff FB, Stek ML, Hoogendijk WJ, Beekman AT. The efficacy and safety of ECT in depressed older adults: a literature review. Int J Geriatr Psychiatry. 2003 Oct;18(10):894-904. doi: 10.1002/gps.944.
18311845	Background	Tielkes CE, Comijs HC, Verwijk E, Stek ML. The effects of ECT on cognitive functioning in the elderly: a review. Int J Geriatr Psychiatry. 2008 Aug;23(8):789-95. doi: 10.1002/gps.1989.

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders