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 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/01/2002
- Registration date
- 15/01/2002
- Last edited
- 06/09/2007
- 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 Kimmo Kuoppasalmi
Scientific
Scientific
National Public Health Institute
Mannerheimintie 166
Helsinki
00300
Finland
| Phone | +358 (0)9 47448701 |
|---|---|
| kimmo.kuoppasalmi@ktl.fi |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/1995 |
| Completion date | 01/02/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Finland
Study participating centre
National Public Health Institute
Helsinki
00300
Finland
00300
Finland
Sponsor information
Helsinki University Central Hospital (Finland)
Hospital/treatment centre
Hospital/treatment centre
Department of Psychiatry
Helsinki
-
Finland
"ROR" |
https://ror.org/02e8hzf44 |
|---|
Funders
Funder type
Government
The Foundation for Psychiatric Research (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/01/2002 | Yes | No |
