Differential response to right unilateral electroconvulsive therapy (ECT) in depressed patients: impact of comorbidity and severity of illness

ISRCTN	ISRCTN39974945
DOI	https://doi.org/10.1186/ISRCTN39974945
Protocol serial number	N/A
Sponsor	Helsinki University Central Hospital (Finland)
Funder	The Foundation for Psychiatric Research (Finland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Kimmo Kuoppasalmi
Scientific

National Public Health Institute
Mannerheimintie 166
Helsinki
00300
Finland

Phone	+358 (0)9 47448701
Email	kimmo.kuoppasalmi@ktl.fi

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/02/1997

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	40
Key inclusion criteria	Patients with a current major depressive episode
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/1995
Date of final enrolment	01/02/1997

National Public Health Institute

Helsinki
00300
Finland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/01/2002		Yes	No