Condition category
Mental and Behavioural Disorders
Date applied
11/04/2008
Date assigned
09/05/2008
Last edited
30/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.kuleuven.be/english

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes