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

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ClinicalTrials.gov Identifier: NCT00258791
Recruitment Status : Withdrawn (first postponed then cancelled as national drug authority changed requirements)
First Posted : November 28, 2005
Last Update Posted : September 25, 2012
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Mental Disorders Drug: Ibuprofen Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pretreatment With Ibuprofen in Post- ECT Headache
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receiving ECT

Exclusion Criteria:

  • Pregnancy, contraindications to ibuprofen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258791


Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Olav Morten Linaker, MD PhD Norwegian University of Science and Technology

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00258791     History of Changes
Other Study ID Numbers: LVS-2005
First Posted: November 28, 2005    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by Norwegian University of Science and Technology:
Psychiatric disorders
ECT
Headache
Ibuprofen

Additional relevant MeSH terms:
Headache
Mental Disorders
Psychotic Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action