Regulation of Intracerebral Pressure During Electroconvul... | NCT00597831

Studies
Regulation of Intracerebral Pressure During Electroconvulsive Therapy

NCT00597831

Sponsor

Rijnstate Hospital

Status

Completed

Last Update Posted

Oct 26, 2010Estimated

Enrollment

16Estimated

Phase

Not provided

Conditions

Depression
Intracranial Pressure

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jan 9, 2008

First Submission Date that Met QC Criteria

Jan 9, 2008

First Posted Date

Jan 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2010

Last Update Posted Date

Oct 26, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.
Study design:

a.Observational study: cohort study
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.
Endpoints:
1. A minimum of sixteen patients are needed according to the power analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulsatility Index before, during and after electroconvulsive therapy		before, during and after three consecutive ECT treatments

Secondary Outcomes

Measure	Description	Time Frame
Bloodpressure before, during and after ECT.		before, during and after three consecutive ECT treatments.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Temporal window to measure PI
Major depression
Psychotic depression

Exclusion Criteria:

Under 18 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roy LE Derikx, MD	Rijnstate Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PAAZ Rijnstate Hospital		Arnhem	Gelderland	6800 TA	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided