Plain English Summary
Not provided at time of registration
Trial website
http://www.kuleuven.be/onderzoek/onderzoeksdatabank/project/3M05/3M050570.htm
Contact information
Type
Scientific
Primary contact
Dr Pascal Sienaert
ORCID ID
Contact details
Leuvensesteenweg 517
Kortenberg
3070
Belgium
pascal.sienaert@uc-kortenberg.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3M050570
Study information
Scientific title
Acronym
BFRUL
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
Ethics approval
Ethics Committee of the Catholic University of Leuven. Date of approval: 11/09/2003 (ref: ML2393)
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Depressive disorder/ bipolar disorder
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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)
Overall trial start date
01/10/2003
Overall trial end date
01/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/10/2003
Recruitment end date
01/10/2007
Locations
Countries of recruitment
Belgium
Trial participating centre
Leuvensesteenweg 517
Kortenberg
3070
Belgium
Sponsor information
Organisation
Catholic University Leuven (Belgium)
Sponsor details
University Psychiatric Centre
Kortenberg campus
Leuvensesteenweg 517
Kortenberg
3070
Belgium
+32 2 758 05 11
pascal.sienaert@gmail.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Catholic University Leuven, University Psychiatric Centre (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Patient satisfaction results
Sienaert PA, Vansteelandt K, Demyttenaere K, Peuskens J, Predictors of patient satisfaction after ultrabrief bifrontal and unilateral electroconvulsive therapies for major depression., J ECT, 2010, 26, 1, 55-59, doi: 10.1097/YCT.0b013e3181ac3c8e.
-
Results
Sienaert P, Vansteelandt K, Demyttenaere K, Peuskens J, Randomized comparison of ultra-brief bifrontal and unilateral electroconvulsive therapy for major depression: clinical efficacy., J Affect Disord, 2009, 116, 1-2, 106-112, doi: 10.1016/j.jad.2008.11.001.