Condition category
Mental and Behavioural Disorders
Date applied
21/06/2007
Date assigned
16/07/2007
Last edited
11/09/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Axel Nordenskjold

ORCID ID

Contact details

Universitetsjukhuset Orebro
Örebro
70185
Sweden
axel.nordenskjold@orebroll.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00627887

Protocol/serial number

070621

Study information

Scientific title

Acronym

Study hypothesis

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.

Please note that as of 21/12/2007, extensive updates have been made to this trial record. This is 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 anticipated start date has also been updated. The previous anticipated 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'.

Please note that as of 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.

Ethics approval

Ethics approval received from the Ethics Committee in Uppsala (Sweden) on the 28th November 2007 (ref: Dnr 2007/301).

Study design

Randomised controlled trial with two parallel groups.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/01/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

100

Participant 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

Recruitment start date

15/01/2008

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Sweden

Trial participating centre

Universitetsjukhuset Orebro
Örebro
70185
Sweden

Sponsor information

Organisation

Orebro County Council (Orebro lans landsting) (Sweden)

Sponsor details

c/o Axel Nordenskjold
Universitetsjukhuset Orebro
Orebro
70185
Sweden
axel.nordenskjold@orebroll.se

Sponsor type

Government

Website

http://www.orebroll.se/uso/page____2834.aspx

Funders

Funder type

Government

Funder name

Regional Research Council of the Uppsala-Orebro Region (Regionala forskningsradet i Uppsala-Orebro regionen) (Sweden)

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

Publication citations

Additional files

Editorial Notes