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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00597831
Other study ID # LTC-491/251007
Secondary ID
Status Completed
Phase N/A
First received January 9, 2008
Last updated October 25, 2010
Start date January 2008
Est. completion date July 2009

Study information

Verified date October 2010
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority Netherlands: Dutch Health Care Inspectorate
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether electroconvulsive therapy (ECT) has an influence on pressure within the human brain before, during and after ECT.


Description:

1. Aim:

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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Temporal window to measure PI

- Major depression

- Psychotic depression

Exclusion Criteria:

- Under 18 years of age

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands PAAZ Rijnstate Hospital Arnhem Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulsatility Index before, during and after electroconvulsive therapy before, during and after three consecutive ECT treatments No
Secondary Bloodpressure before, during and after ECT. before, during and after three consecutive ECT treatments. No
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