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

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105064
• Other study ID #: 10-0426
• Status: Completed
• Phase: N/A
• First received: September 16, 2013
• Last updated: March 7, 2016
• Start date: July 2011
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Schizophrenia (DSM-IV-TR)

• YBOCS = 16

Exclusion Criteria:

• Mental Retardation

• Substance abuse

• Any contraindication to rTMS

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obsessive-Compulsive Symptoms
• Schizophrenia

Intervention

Device:
• Active rTMS
rTMS over supplementary motor area, 1hz, no pauses, 20 minutes/sessions, 5 sessions/week, 4 weeks. Total 20 sessions.
• SHAM rTMS
Sham rTMS, without brain stimulation

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No