The purpose of the study is to determine wether ibuprofen reduce post-ECT headache or reduce its severity...
Date First Received: November 24, 2005
Last Updated: April 18, 2008
Verified by: Norwegian University of Science and Technology, April 2008
Clinical Trial Phase: N/A | Start Date: August 2008
Overall Status: Not yet recruiting
Estimated Enrollment: 30
Brief Summary
Official Title: “Effects of Pretreatment With Ibuprofen in Post- ECT Headache”
Condition Keyword(s):
Intervention(s):
The purpose of the study is to determine wether ibuprofen reduce post-ECT headache or reduce its severity.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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].
Outcome Measures for this Clinical Trial
Primary:
- Score on depression rating scale prior to and after ECT treatment
- score on headache prior to and after ECT treatment
Secondary:
- ECT parameters
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients receiving ECT
Exclusion Criteria:
- Pregnancy, contraindications to ibuprofen
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Norwegian University of Science and Technology
Østmarka Psychiatric Department, St. OLavs Hospital, University Hospital of Trondheim
Trondheim Norway
Overall Clinical Trial Officials and Contacts
Olav Morten Linaker, MD PhD Principal Investigator Norwegian University of Science and Technology
Overall Contact: Lindy Jarosch-von Schweder, MD 47 73864533 lindy.jarosch@ntnu.no
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00258791
Study ID Number: LVS-2005
ClinicalTrials.gov Identifier: NCT00258791
Health Authority: Norway: Norwegian Social Science Data Services
Clinical Trials Authorship and Review
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