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
Study Primary Completion Date: December 2009
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].
Intervention(s) in this Clinical Trial
- Drug: Ibuprofen
Outcome Measures for this Clinical Trial
Primary Measures
- Score on depression rating scale prior to and after ECT treatment
- score on headache prior to and after ECT treatment
Secondary Measures
- ECT parameters
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients receiving ECT
Exclusion Criteria:
- Pregnancy, contraindications to ibuprofen
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Norwegian University of Science and Technology
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 02, 2009
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
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