Randomised controlled trial of electroconvulsive therapy (ECT) with pharmacotherapy or pharmacotherapy alone in relapse prevention of depression
| ISRCTN | ISRCTN40355220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40355220 |
| ClinicalTrials.gov number | NCT00627887 |
| Secondary identifying numbers | 070621 |
- Submission date
- 21/06/2007
- Registration date
- 16/07/2007
- Last edited
- 14/02/2019
- 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 Axel Nordenskjold
Scientific
Scientific
Universitetsjukhuset Orebro
Örebro
70185
Sweden
| axel.nordenskjold@orebroll.se |
Study information
| Study design | Randomised controlled trial with two parallel groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised controlled trial of electroconvulsive therapy (ECT) with pharmacotherapy or pharmacotherapy alone in relapse prevention of depression |
| Study objectives | Current hypothesis as of 21/12/2007: Electroconvulsive therapy (ECT) and pharmacotherapy combined is more effective than pharmacotherapy alone. Previous hypothesis: Electroconvulsive therapy (ECT) and pharmacotherapy combined is more efficient than pharmacotherapy alone and ECT alone. |
| Ethics approval(s) | Ethics Committee in Uppsala (Sweden), 28/11/2007, ref: Dnr 2007/301 |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | Current interventions as of 25/07/2008: The patients will have ECT three times weekly in the index series (before the trial). ECT: During the trial the patients have unilateral ECT weekly for the first six weeks then every other week for 46 weeks. Pharmacotherapy: Pharmacotherapy will include treatment with venlafaxine target dose 300 mg/d within the first four weeks combined with lithium dosed according to serum-concentration 0.5 - 0.8 mmol/L. Previous interventions: The patients will have ECT three times weekly in the index series (before the trial). ECT: During the trial the patients have unilateral ECT weekly for the first six weeks then every other week for 46 weeks. Pharmacotherapy: Pharmacotherapy will include treatment with venlafaxine target dose 300 mg/d within the first four weeks combined with lithium dosed according to serum-concentration 0.5 - 0.9 mmol/L. |
| Intervention type | Mixed |
| Primary outcome measure | Relapse, defined as either: 1. Rehospitalisation in a psychiatric ward, or 2. More than 20 on the MADRS interview. MADRS-S self-assessment is provided weekly for the first six weeks then every other week. |
| Secondary outcome measures | Current secondary outcome measures as of 21/12/2007: 1. Memory problems measured with: 1.1. Mini Mental State Examination (MMSE) 1.2. Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog) 1.3. At one site the Autobiographical Memory Inventory Short Form will also be used 2. Medication Side-effects measured with the Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale Patients are assessed at 2 months, 6 months and 12 months after randomization and at relapse. Previous secondary outcome measures: 1. Side-effects measured with the Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale self-assemessment 2. Memory problems measured with Mini Mental State Examination (MMSE), Squire Subjective Memory Questionnaire and the Autobiographical Memory Inventory Short Form 3. Quality of life is measured with 36-item Short Form health survey (SF-36) Patients are assessed after 2 months, 6 months and 12 months and at relapse. |
| Overall study start date | 15/01/2008 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Current inclusion criteria as of 25/07/2008: 1. Mini International Neuropsychiatry Interview Plus (MINI-PLUS) verified major depressive episode (unipolar or bipolar) 2. ECT within the last 3 weeks 3. Either remission defined as Montgomery-Asberg Depression Rating Scale (MADRS) less than 10, or 4. Response defined as MADRS less than 15 combined with patient assessed Clinical Global Impressions-Improvement Scale (CGI-I) of at least much improved Previous inclusion criteria: 1. Patients treated with ECT for Diagnostic and Statistical Manual of mental disorders - Fourth Edition (DSM-IV-TR) diagnosis of major depression 2. Remission (less than 10 on the Montgomery-Asberg Depression Rating Scale [MADRS]) 3. Informed consent |
| Key exclusion criteria | Current exclusion criteria as of 25/07/2008: 1. Schizophrenia or schizoaffective disorder 2. Addiction or dependence 3. Kidney disease that contraindicates lithium treatment 4. Vascular or heart disease that contraindicates venlafaxine treatment 5. Uncontrolled epilepsia 6. Aged less that 18 years 7. Pregnancy or lactation Previous exclusion criteria: 1. Bipolar 1 disorder 2. Schizophrenia and schizoaffective diagnosis 3. Abuse or dependence diagnosis 4. Kidney disease 5. Heart disease 6. Epilepsia 7. More than three weeks since index ECT 8. Under 16 years of age, more than 10 on the MADRS after 12 index ECT |
| Date of first enrolment | 15/01/2008 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Universitetsjukhuset Orebro
Örebro
70185
Sweden
70185
Sweden
Sponsor information
Orebro County Council (Orebro lans landsting) (Sweden)
Government
Government
c/o Axel Nordenskjold
Universitetsjukhuset Orebro
Orebro
70185
Sweden
| axel.nordenskjold@orebroll.se | |
| Website | http://www.orebroll.se/uso/page____2834.aspx |
"ROR" |
https://ror.org/00maqj547 |
Funders
Funder type
Government
Regional Research Council of the Uppsala-Orebro Region (Regionala forskningsradet i Uppsala-Orebro regionen) (Sweden)
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 | 01/06/2013 | 14/02/2019 | Yes | No |
Editorial Notes
14/02/2019: Publication reference added.
25/07/2008: The inclusion and exclusion criteria of this record were updated. The serum concentration of the lithium was also updated. All changes can be seen under the relevant fields under the update date of 25/07/2008.
21/12/2007: Extensive updates were made due to a change in the protocol which has meant that there are now only two treatment arms:
1. ECT and pharmacotherapy
2. Pharmacotherapy alone
All updates to this trial record due to this protocol change can be found under the date 21/12/2007. Please also note that the overall trial start date has also been updated. The previous overall trial start date was 01/11/2007. The trial title has also changed (as above). The previous trial title was 'Randomised controlled trial of ElectroConvulsive Therapy (ECT), pharmacotherapy or ECT and Pharmacotherapy combined in Relapse prevention after successful ECT for depression'.
