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 (NCT)	NCT00627887
Protocol serial number	070621
Sponsor	Orebro County Council (Orebro lans landsting) (Sweden)
Funder	Regional Research Council of the Uppsala-Orebro Region (Regionala forskningsradet i Uppsala-Orebro regionen) (Sweden)

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

Universitetsjukhuset Orebro
Örebro
70185
Sweden

Email	axel.nordenskjold@orebroll.se

Study information

Primary study design	Interventional
Study design	Randomised controlled trial with two parallel groups
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

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	01/06/2013	14/02/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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'.