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

Not Applicable

Completed

• Conditions: Schizophrenia; Obsessive-Compulsive Symptoms
• Interventions: Device: Active rTMS; Device: SHAM rTMS

• Registration Number: NCT02105064
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Primary Completion: 2014-12
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• Mental Retardation
• Substance abuse
• Any contraindication to rTMS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS	Active rTMS	rTMS over Supplementary Motor Area, 1hz, no pauses, 20 minutes per sessions. Total: 20 sessions.
Sham	SHAM rTMS	Sham stimulation, 20 minutes per session, total 20 sessions

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change of Psychotic Symptoms (using Brief Psychiatric Rating Scale - BPRS)	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)	Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil