Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant Obsessive-compulsive Symptoms in Patients With Schizophrenia
Primary Purpose
Schizophrenia, Obsessive-Compulsive Symptoms
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active rTMS
SHAM rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Schizophrenia (DSM-IV-TR)
- YBOCS ≥ 16
Exclusion Criteria:
- Mental Retardation
- Substance abuse
- Any contraindication to rTMS
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active rTMS
Sham
Arm Description
rTMS over Supplementary Motor Area, 1hz, no pauses, 20 minutes per sessions. Total: 20 sessions.
Sham stimulation, 20 minutes per session, total 20 sessions
Outcomes
Primary Outcome Measures
Change of Obsessive Compulsive symptoms (using Yale-Brown Obsessive Compulsive Scale - Y-BOCS)
Secondary Outcome Measures
Change of Psychotic Symptoms (using Brief Psychiatric Rating Scale - BPRS)
Change of Brain-Derived Neurotrophic Factor (BDNF)
Full Information
NCT ID
NCT02105064
First Posted
September 16, 2013
Last Updated
March 7, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT02105064
Brief Title
Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant Obsessive-compulsive Symptoms in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms in patients with schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Obsessive-Compulsive Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active rTMS
Arm Type
Active Comparator
Arm Description
rTMS over Supplementary Motor Area, 1hz, no pauses, 20 minutes per sessions. Total: 20 sessions.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham stimulation, 20 minutes per session, total 20 sessions
Intervention Type
Device
Intervention Name(s)
Active rTMS
Intervention Description
rTMS over supplementary motor area, 1hz, no pauses, 20 minutes/sessions, 5 sessions/week, 4 weeks. Total 20 sessions.
Intervention Type
Device
Intervention Name(s)
SHAM rTMS
Intervention Description
Sham rTMS, without brain stimulation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Schizophrenia (DSM-IV-TR)
YBOCS ≥ 16
Exclusion Criteria:
Mental Retardation
Substance abuse
Any contraindication to rTMS
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant Obsessive-compulsive Symptoms in Patients With Schizophrenia
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