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Regulation of Intracerebral Pressure During Electroconvulsive Therapy

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ClinicalTrials.gov Identifier: NCT00597831
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : October 26, 2010
Sponsor:
Information provided by:
Rijnstate Hospital

Brief 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.

Condition or disease
Depression Intracranial Pressure

Detailed 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.

Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulation of Intracerebral Pressure During Electroconvulsive Therapy. Does Systemic Bloodpressure Reflect the Intracranial Pressure?
Study Start Date : January 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Pulsatility Index before, during and after electroconvulsive therapy [ Time Frame: before, during and after three consecutive ECT treatments ]

Secondary Outcome Measures :
  1. Bloodpressure before, during and after ECT. [ Time Frame: before, during and after three consecutive ECT treatments. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients indicated for unilateral ECT treatment in the Rijnstate Hospital with the diagnosis major depression and psychotic depressionaccording to DSM IV-TR classification. Patients who already started treatment and patients just starting ECT and are of age > 18 years.
Criteria

Inclusion Criteria:

  • Temporal window to measure PI
  • Major depression
  • Psychotic depression

Exclusion Criteria:

  • Under 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597831


Locations
Netherlands
PAAZ Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: Roy LE Derikx, MD Rijnstate Hospital

Responsible Party: Derikx, MD, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT00597831     History of Changes
Other Study ID Numbers: LTC-491/251007
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: October 2010

Keywords provided by Rijnstate Hospital:
depression
electroconvulsive therapy
Ultrasonography Doppler Transcranial
intracranial pressure

Additional relevant MeSH terms:
Depression
Behavioral Symptoms