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

Mental Disorders Clinical Trial

Official title:

Effects of Pretreatment With Ibuprofen in Post- ECT Headache

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00258791
• Other study ID #: LVS-2005
• Status: Withdrawn
• Phase: N/A
• First received: November 24, 2005
• Last updated: September 21, 2012
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: September 2012
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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

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].

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients receiving ECT

Exclusion Criteria:

• Pregnancy, contraindications to ibuprofen

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Ibuprofen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology