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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00258791
First received: November 24, 2005
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

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

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

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: September 21, 2012
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 May 23, 2013