Regulation of Intracerebral Pressure During Electroconvulsive Therapy

This study has been completed.
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00597831
First received: January 9, 2008
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

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
Depression
Intracranial Pressure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulation of Intracerebral Pressure During Electroconvulsive Therapy. Does Systemic Bloodpressure Reflect the Intracranial Pressure?

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • Pulsatility Index before, during and after electroconvulsive therapy [ Time Frame: before, during and after three consecutive ECT treatments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bloodpressure before, during and after ECT. [ Time Frame: before, during and after three consecutive ECT treatments. ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: January 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Derikx, MD, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT00597831     History of Changes
Other Study ID Numbers: LTC-491/251007
Study First Received: January 9, 2008
Last Updated: October 25, 2010
Health Authority: Netherlands: Dutch Health Care Inspectorate

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014