Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant Obsessive-compulsive Symptoms in Patients With Schizophrenia

March 7, 2016 updated by: Hospital de Clinicas de Porto Alegre
This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms in patients with schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital De Clinicas De Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Schizophrenia (DSM-IV-TR)
  • YBOCS ≥ 16

Exclusion Criteria:

  • Mental Retardation
  • Substance abuse
  • Any contraindication to rTMS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active rTMS
rTMS over Supplementary Motor Area, 1hz, no pauses, 20 minutes per sessions. Total: 20 sessions.
Device: Active rTMS
rTMS over supplementary motor area, 1hz, no pauses, 20 minutes/sessions, 5 sessions/week, 4 weeks. Total 20 sessions.
Sham Comparator: Sham
Sham stimulation, 20 minutes per session, total 20 sessions
Device: SHAM rTMS
Sham rTMS, without brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of Obsessive Compulsive symptoms (using Yale-Brown Obsessive Compulsive Scale - Y-BOCS)
Time Frame: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Psychotic Symptoms (using Brief Psychiatric Rating Scale - BPRS)
Time Frame: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Change of Brain-Derived Neurotrophic Factor (BDNF)
Time Frame: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 16, 2013

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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