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Randomised comparison of bifrontal and unilateral ultrabrief pulse electroconvulsive therapy in major depression
ISRCTN ISRCTN56570426
DOI 10.1186/ISRCTN56570426
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised comparison of bifrontal and unilateral ultrabrief pulse electroconvulsive therapy in major depression
Scientific title
Acronym BFRUL
Serial number at source 3M050570
Study hypothesis 1. Ultrabrief bifrontal electroconvulsive therapy (ECT) is as effective as ultrabrief unilateral ECT
2. Ultrabrief bifrontal ECT produces less cognitive side-effects than ultrabrief unilateral ECT
Lay summary
Ethics approval Ethics Committee of the Catholic University of Leuven. Date of approval: 11/09/2003 (ref: ML2393)
Study design Randomised controlled trial.
Countries of recruitment Belgium
Disease/condition/study domain Depressive disorder/ bipolar disorder
Participants - inclusion criteria 1. Aged 18 years or older
2. Patients with Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV)-defined major depressive disorder, either bipolar or unipolar, with or without psychotic symptoms
3. Those who were referred for ECT
4. Those who had a minimum baseline score of 18 on the 17-item Hamilton Rating Scale for Depression (HRSD)
5. Written informed consent
Participants - exclusion criteria 1. Schizophrenia
2. Neurological illness
3. Cognitive disorder
4. Substance abuse or dependence within the previous year
5. ECT within the past 6 months
Anticipated start date 01/10/2003
Anticipated end date 01/10/2007
Status of trial Completed
Patient information material
Target number of participants 60
Interventions Ultrabrief bifrontal ECT vs ultrabrief unilateral ECT. Patients were treated twice weekly until remission and had a mean number of treatment sessions of 11.

Ultrabrief pulse ECT = pulse width of 0.3 msec.
Primary outcome measure(s) The following were performed at baseline and once every week until response/remission, and 1 and 6 weeks after finishing the course, by a blinded rater:
1. Hamilton Depression Rating Scale (HDRS)
2. Beck Depression Inventory (BDI)
3. Clinical Global Impression (CGI)
4. Patient Global Impression (PGI)
Secondary outcome measure(s) The following were assessed at baseline and 1 and 6 weeks after finishing the course:
1. Mini Mental State Examination (MMSE)
2. Trail Making Test A&B
3. Continuous Performance Task (CPT)
4. Wisconsin Card Sorting Test (WCST)
5. Rey's Auditory Verbal Learning Test (RAVLT)
6. Letter Number Sequencing (WAIS)
7. Autobiographical Memory Test (AMT)
8. Autobiographical Memory Interview (AMI)
9. Squire Subjective Memory Questionnaire (SSMQ)
Sources of funding Catholic University Leuven, University Psychiatric Centre (Belgium)
Trial website http://www.kuleuven.be/onderzoek/onderzoeksdatabank/project/3M05/3M050570.htm
Publications 1. 2009 patient satisfaction results in http://www.ncbi.nlm.nih.gov/pubmed/19458534
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19081638
Contact name Dr  Pascal  Sienaert
  Address Leuvensesteenweg 517
  City/town Kortenberg
  Zip/Postcode 3070
  Country Belgium
  Email pascal.sienaert@uc-kortenberg.be
Sponsor Catholic University Leuven (Belgium)
  Address University Psychiatric Centre
Kortenberg campus
Leuvensesteenweg 517
  City/town Kortenberg
  Zip/Postcode 3070
  Country Belgium
  Tel +32 2 758 05 11
  Fax +32 2 759 53 80
  Email pascal.sienaert@gmail.com
  Sponsor website: http://www.kuleuven.be/english
Date applied 11/04/2008
Last edited 30/06/2009
Date ISRCTN assigned 09/05/2008
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