Regulation of Intracerebral Pressure During Electroconvulsive Therapy
NCT ID: NCT00597831
Last Updated: 2010-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2008-01-31
2009-07-31
Brief Summary
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Detailed Description
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1. Our main objective concerning this study is to determine to what extent ECT does lead to an increase of the Pulsatility Index (as an indicator of intracerebral pressure) measured by a Transcranial Doppler Device (TCD).
2. As a secondary objective we want to compare the PI measurements with simultaneously measured systemic blood pressure.
2. Study design:
a.Observational study: cohort study
3. Treatment:
a. Treatment as usual, PI and blood pressure measurement at baseline, just before ECT, during and 5 minutes after ECT. Data will be collected during unilateral treatment during 3 consecutive ECT treatments.
4. Endpoints:
1. A minimum of sixteen patients are needed according to the power analysis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A
All patients in the Rijnstate Hospital with an indication for unilateral ECT treatment and a major depression or psychotic depression according to DSM IV-TR criteria.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Major depression
* Psychotic depression
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Rijnstate Hospital
OTHER
Responsible Party
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Rijnstate Hospital
Principal Investigators
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Roy LE Derikx, MD
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital
Locations
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PAAZ Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Countries
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Other Identifiers
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LTC-491/251007
Identifier Type: -
Identifier Source: org_study_id