NCT01015001

Brief Summary

The primary outcome of this study is to evaluate the effects of low frequency subthreshold repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of patients with refractory schizophrenia on the severity of auditory hallucinations. The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of life, functionality and general psychopathology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started May 2008

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

May 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 12, 2010

Status Verified

August 1, 2010

Enrollment Period

1.6 years

First QC Date

November 10, 2009

Last Update Submit

August 11, 2010

Conditions

SchizophreniaAuditory Hallucinations

Keywords

refractory schizophreniarTMSauditory hallucinations

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effects of low frequency repetitive Transcranial Magnetic Stimulation applied over the left temporoparietal cortex of refractory schizophrenic patients on the severity of auditory hallucinations.

    2 years

Secondary Outcomes (1)

  • The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.

    2 years

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects

Procedure: Active rTMS x sham (placebo) rTMSProcedure: (1Hz) rTMS applied over the left temporoparietal cortex

Sham rtms

PLACEBO COMPARATOR

Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region

Procedure: Active rTMS x sham (placebo) rTMSProcedure: sham rTMS

Interventions

Active rTMS x sham (placebo) rTMSPROCEDURE

Seventeen right-handed patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. One arm received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC). The other arm received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and referred auditory hallucinations.

Also known as: EMTr
Active rTMSSham rtms
sham rTMSPROCEDURE

same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region

Also known as: Sham
Sham rtms
(1Hz) rTMS applied over the left temporoparietal cortexPROCEDURE

20 sessions lasting 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).

Active rTMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with DSM IV TR diagnose of schizophrenia with treatment-resistant auditory hallucinations.
  • Use of at least 400mg/day of clozapine
  • Men and women from 18 to 65 years old
  • Fertile women must be using adequate contraceptive method
  • BPRS score of at least 27

You may not qualify if:

  • Suicide risk
  • Patients with epilepsy, brain surgery and/or head trauma in the past, use of cardiac pace maker or metalic clip in the head
  • Diagnose of substance abuse/dependance
  • Severe uncontrolled organic disease that may interfere in the patient´s participation in the study
  • Any other reason that, in the investigator´s opinion, might interfere with the patient´s participation in the study, such as non compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

SchizophreniaHallucinationsSchizophrenia, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulationsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Danilo Jesus, Psychiatrist

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Paulo B Abreu, phd

    HCPorto Alegre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 17, 2009

Study Start

May 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 12, 2010

Record last verified: 2010-08

Locations

BR(1)