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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

Tracking Information
First Submitted Date  ICMJE September 16, 2013
First Posted Date  ICMJE April 7, 2014
Last Update Posted Date March 8, 2016
Study Start Date  ICMJE July 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02105064 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant Obsessive-compulsive Symptoms in Patients With Schizophrenia
Official Title  ICMJE Not Provided
Brief Summary This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms in patients with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Obsessive-Compulsive Symptoms
Intervention  ICMJE
  • Device: Active rTMS
    rTMS over supplementary motor area, 1hz, no pauses, 20 minutes/sessions, 5 sessions/week, 4 weeks. Total 20 sessions.
  • Device: SHAM rTMS
    Sham rTMS, without brain stimulation
Study Arms  ICMJE
  • Active Comparator: Active rTMS
    rTMS over Supplementary Motor Area, 1hz, no pauses, 20 minutes per sessions. Total: 20 sessions.
    Intervention: Device: Active rTMS
  • Sham Comparator: Sham
    Sham stimulation, 20 minutes per session, total 20 sessions
    Intervention: Device: SHAM rTMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental Retardation
  • Substance abuse
  • Any contraindication to rTMS
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02105064
Other Study ID Numbers  ICMJE 10-0426
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE Not Provided
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP