CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 92 enrolled
Drug / intervention
ECT +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01559324
NCT01559324Phase 4Completed
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Randomized Controlled Comparison of Bifrontal and Right Unilateral ECT as to Effects on Depression, Global Cognitive Function and Biomarkers.

Diakonhjemmet Hospital·interventional·Posted Mar 21, 2012·Updated Jul 9, 2015

In Brief

A Phase 4 clinical trial evaluating ECT for Major Depression. Completed, enrolled 92 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depression
CountriesNorway
CollaboratorsMD Tor Magne Bjølseth, MD Torfinn Lødøen Gaarden

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 21, 2012
Enrollment StartAug 1, 2009
Primary CompletionJul 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.3 years ago

Interventions

ECTdevice

Bifrontal ECT, low dosage

ECTdevice

Right unilateral electrode position, high dosage