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

This study is not yet open for participant recruitment.

Verified by Norwegian University of Science and Technology, April 2008

Sponsored by:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00258791

Purpose

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

Condition	Intervention
Mental Disorders	Drug: Ibuprofen

MedlinePlus related topics: Headache Mental Health

Drug Information available for: Ibuprofen Dexibuprofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Effects of Pretreatment With Ibuprofen in Post- ECT Headache

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

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

Secondary Outcome Measures:

ECT parameters

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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].

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients receiving ECT

Exclusion Criteria:

Pregnancy, contraindications to ibuprofen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258791

Contacts

Contact: Lindy Jarosch-von Schweder, MD

47 73864533

lindy.jarosch@ntnu.no

Locations

Norway
Østmarka Psychiatric Department, St. OLavs Hospital, University Hospital of Trondheim
Trondheim, Norway

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Principal Investigator:

Olav Morten Linaker, MD PhD

Norwegian University of Science and Technology

More Information

Responsible Party:	Norwegian University of Science and Technology ( Olav Linaker, Professor MD )
Study ID Numbers:	LVS-2005
Study First Received:	November 24, 2005
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00258791
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Psychiatric disorders
ECT
Headache
Ibuprofen

Study placed in the following topic categories:

Signs and Symptoms
Ibuprofen
Mental Disorders

Headache
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009