Condition category
Mental and Behavioural Disorders
Date applied
15/01/2002
Date assigned
15/01/2002
Last edited
06/09/2007
Prospective/Retrospective
Retrospectively 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 Kimmo Kuoppasalmi

ORCID ID

Contact details

National Public Health Institute
Mannerheimintie 166
Helsinki
00300
Finland
+358 (0)9 47448701
kimmo.kuoppasalmi@ktl.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Major depressive episode

Intervention

Right unilateral electroconvulsive therapy dosed at 2.5 or 5 times the initial seizure threshold. Planned study population (n = 40; Group 1, n = 16; Group 2, n = 24), together with inclusion/exclusion criteria.

Group 1 patients had major depression (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]) with severity of the major depressive episode greater than 16 scores on 17-item Hamilton Rating Scale for Depression. Group 2 patients had a less severe major depressive episode or some comorbid condition.

Main comparative analyses between primary outcome measures were completed on an intention-to-treat basis. Randomisation by computer using a block with six patients per block. Assignment was concealed until administration of the first randomised treatment. All evaluators (the attending physicians and the raters) and the patients were blinded to the assignment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1995

Overall trial end date

01/02/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with a current major depressive episode

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/1995

Recruitment end date

01/02/1997

Locations

Countries of recruitment

Finland

Trial participating centre

National Public Health Institute
Helsinki
00300
Finland

Sponsor information

Organisation

Helsinki University Central Hospital (Finland)

Sponsor details

Department of Psychiatry
Helsinki
-
Finland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

The Foundation for Psychiatric Research (Finland)

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11846888

Publication citations

  1. Results

    Heikman P, Katila H, Sarna S, Wahlbeck K, Kuoppasalmi K, Differential response to right unilateral ECT in depressed patients: impact of comorbidity and severity of illness [ISRCTN39974945]., BMC Psychiatry, 2002, 2, 2.

Additional files

Editorial Notes