Effects of Pretreatment With Ibuprofen in Post-Electroconvulsive Therapy (ECT) Headache

This study has been withdrawn prior to enrollment.

(first postponed then cancelled as national drug authority changed requirements)

Sponsor:

Information provided by (Responsible Party):

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT00258791

First received: November 24, 2005

Last updated: September 21, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 24, 2005

Last Updated Date

September 21, 2012

Start Date ^ICMJE

January 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Score on depression rating scale prior to and after ECT treatment
score on headache prior to and after ECT treatment

Change History

Complete list of historical versions of study NCT00258791 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

ECT paramenters

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Pretreatment With Ibuprofen in Post-Electroconvulsive Therapy (ECT) Headache

Official Title ^ICMJE

Effects of Pretreatment With Ibuprofen in Post- ECT Headache

Brief Summary

The purpose of the study is to determine whether ibuprofen reduces post-ECT headache or reduces its severity.

Detailed Description

The aim of the study is to compare the severity of headache between patients who are receiving ibuprofen prior to ECT treatment with patients receiving placebo prior to ECT treatment.

Patients will be randomly assigned to receive either 600 mg ibuprofen 90 min prior to treatment or placebo orally, blinded to patient, physician and treatment team.

Patients will be asked about their headache with a visual analogue scale (VAS) 2 hours prior to and within 2 hours after treatment, 2-month, 6- month and 1 year follow-up [5].

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Mental Disorders

Intervention ^ICMJE

Drug: Ibuprofen

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

May 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients receiving ECT

Exclusion Criteria:

Pregnancy, contraindications to ibuprofen

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00258791

Other Study ID Numbers ^ICMJE

LVS-2005

Has Data Monitoring Committee

Responsible Party

Norwegian University of Science and Technology

Study Sponsor ^ICMJE

Norwegian University of Science and Technology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Olav Morten Linaker, MD PhD

Norwegian University of Science and Technology

Information Provided By

Norwegian University of Science and Technology

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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