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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN39974945 |
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Date of registration:
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15/01/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Differential response to right unilateral electroconvulsive therapy (ECT) in depressed patients: impact of comorbidity and severity of illness
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Scientific title:
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Date of first enrolment:
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01/10/1995 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN39974945 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Finland
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Kimmo
Kuoppasalmi |
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Address:
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National Public Health Institute
Mannerheimintie 166
00300
Helsinki
Finland |
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Telephone:
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+358 (0)9 47448701 |
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Email:
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kimmo.kuoppasalmi@ktl.fi |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with a current major depressive episode
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Major depressive episode
Mental and Behavioural Disorders
Depression
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Intervention(s)
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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.
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Primary Outcome(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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The Foundation for Psychiatric Research (Finland)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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