Randomised comparison of bifrontal and unilateral ultrabrief pulse electroconvulsive therapy in major depression

ISRCTN	ISRCTN56570426
DOI	https://doi.org/10.1186/ISRCTN56570426
Protocol serial number	3M050570
Sponsor	Catholic University Leuven (Belgium)
Funder	Catholic University Leuven, University Psychiatric Centre (Belgium)

Submission date: 11/04/2008
Registration date: 09/05/2008
Last edited: 30/06/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pascal Sienaert
Scientific

Leuvensesteenweg 517
Kortenberg
3070
Belgium

Email	pascal.sienaert@uc-kortenberg.be

Study information

Primary study design	Interventional
Study design	Randomised controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	BFRUL
Study objectives	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(s)	Ethics Committee of the Catholic University of Leuven. Date of approval: 11/09/2003 (ref: ML2393)
Health condition(s) or problem(s) studied	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
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)
Key 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)
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/10/2003
Date of final enrolment	01/10/2007

Locations

Countries of recruitment

Belgium

Study participating centre

Leuvensesteenweg 517

Kortenberg
3070
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2009		Yes	No
Results article	patient satisfaction results	01/03/2010		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes