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13 May 2008
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| [ Print-friendly version ] |
| Randomised comparison of bifrontal and unilateral ultrabrief pulse electroconvulsive therapy in major depression |
| ISRCTN | ISRCTN56570426 |
| ClinicalTrials.gov identifier | |
| 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 |
| 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 | |
| Contact name | Dr Pascal Sienaert |
| Address | Leuvensesteenweg 517 |
| City/town | Kortenberg |
| Zip/Postcode | 3070 |
| Country | Belgium |
| 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 |
| pascal.sienaert@gmail.com | |
| Sponsor website: | http://www.kuleuven.be/english |
| Date applied | 11/04/2008 |
| Last edited | 09/05/2008 |
| Date ISRCTN assigned | 09/05/2008 |
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