NCT02105064

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

3.4 years

First QC Date

September 16, 2013

Last Update Submit

March 7, 2016

Conditions

SchizophreniaObsessive-Compulsive Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

rTMS over Supplementary Motor Area, 1hz, no pauses, 20 minutes per sessions. Total: 20 sessions.

Device: Active rTMS

Sham

SHAM COMPARATOR

Sham stimulation, 20 minutes per session, total 20 sessions

Device: SHAM rTMS

Interventions

Active rTMSDEVICE

rTMS over supplementary motor area, 1hz, no pauses, 20 minutes/sessions, 5 sessions/week, 4 weeks. Total 20 sessions.

Active rTMS
SHAM rTMSDEVICE

Sham rTMS, without brain stimulation

Sham

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Mental Retardation
  • Substance abuse
  • Any contraindication to rTMS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2013

First Posted

April 7, 2014

Study Start

July 1, 2011

Primary Completion

December 1, 2014

Study Completion

February 1, 2016

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

BR(1)