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

This study has been withdrawn prior to enrollment.
(first postponed then cancelled as national drug authority changed requirements)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00258791
First Posted: November 28, 2005
Last Update Posted: September 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pretreatment With Ibuprofen in Post- ECT Headache

Resource links provided by NLM:


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

Enrollment: 0
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients receiving ECT

Exclusion Criteria:

  • Pregnancy, contraindications to ibuprofen
  Contacts and Locations
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
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00258791     History of Changes
Other Study ID Numbers: LVS-2005
First Submitted: November 24, 2005
First Posted: November 28, 2005
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


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