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

This study is not yet open for participant recruitment.

Verified August 2011 by Norwegian University of Science and Technology

First Received on November 24, 2005. Last Updated on August 26, 2011 History of Changes

Sponsor:	Norwegian University of Science and Technology
Information provided by (Responsible Party):	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00258791

Purpose

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

Condition	Intervention
Mental Disorders	Drug: Ibuprofen

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Pretreatment With Ibuprofen in Post- ECT Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache Mental Disorders Psychotic Disorders

Drug Information available for: Ibuprofen

U.S. FDA Resources

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

Estimated Enrollment:	30
Study Start Date:	January 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	January 2013 (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	Not yet recruiting
Trondheim, Norway
Contact: Lindy Jarosch-von Schweder, MD 47 73864533 lindy.jarosch@ntnu.no
Principal Investigator: Olav Morten Linaker, MD PhD

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

No publications provided

Responsible Party:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00258791 History of Changes
Other Study ID Numbers:	LVS-2005
Study First Received:	November 24, 2005
Last Updated:	August 26, 2011
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Psychiatric disorders
ECT
Headache
Ibuprofen

Additional relevant MeSH terms:

Mental Disorders
Psychotic Disorders
Headache
Schizophrenia and Disorders with Psychotic Features
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012