Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

Randomized Controlled Comparison of Bifrontal and Right Unilateral ECT as to Effects on Depression, Global Cognitive Function and Biomarkers.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01559324

Enrollment

Registered

2012-03-21

Start date

2009-08-31

Completion date

2013-11-30

Last updated

2015-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

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).

Interventions

DEVICEECT

Bifrontal ECT, low dosage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026