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

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ClinicalTrials.gov Identifier: NCT02105064
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Obsessive-Compulsive Symptoms Device: Active rTMS Device: SHAM rTMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental Retardation
  • Substance abuse
  • Any contraindication to rTMS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105064


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02105064     History of Changes
Other Study ID Numbers: 10-0426
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders