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

Primary Purpose

Mental Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ibuprofen
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Psychiatric disorders, ECT, Headache, Ibuprofen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients receiving ECT Exclusion Criteria: Pregnancy, contraindications to ibuprofen

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 24, 2005
    Last Updated
    September 21, 2012
    Sponsor
    Norwegian University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00258791
    Brief Title
    Effects of Pretreatment With Ibuprofen in Post-Electroconvulsive Therapy (ECT) Headache
    Official Title
    Effects of Pretreatment With Ibuprofen in Post- ECT Headache
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    first postponed then cancelled as national drug authority changed requirements
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    May 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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].

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorders
    Keywords
    Psychiatric disorders, ECT, Headache, Ibuprofen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ibuprofen

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients receiving ECT Exclusion Criteria: Pregnancy, contraindications to ibuprofen
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olav Morten Linaker, MD PhD
    Organizational Affiliation
    Norwegian University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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