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

NCT ID: NCT00258791

Last Updated: 2012-09-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-05-31

Brief Summary

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

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].

Conditions

Mental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Ibuprofen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients receiving ECT

Exclusion Criteria

• Pregnancy, contraindications to ibuprofen

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olav Morten Linaker, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Other Identifiers

LVS-2005

Identifier Type: -

Identifier Source: org_study_id