Randomised comparison of bifrontal and unilateral ultrabrief pulse electroconvulsive therapy in major depression
| ISRCTN | ISRCTN56570426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56570426 |
| Secondary identifying numbers | 3M050570 |
- 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
Scientific
Leuvensesteenweg 517
Kortenberg
3070
Belgium
| pascal.sienaert@uc-kortenberg.be |
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/10/2003 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
3070
Belgium
Sponsor information
Catholic University Leuven (Belgium)
University/education
University/education
University Psychiatric Centre
Kortenberg campus
Leuvensesteenweg 517
Kortenberg
3070
Belgium
| Phone | +32 2 758 05 11 |
|---|---|
| pascal.sienaert@gmail.com | |
| Website | http://www.kuleuven.be/english |
"ROR" |
https://ror.org/05f950310 |
Funders
Funder type
University/education
Catholic University Leuven, University Psychiatric Centre (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
