NCT00763841

Brief Summary

Transcranial magnetic stimulation (TMS) involves the use of magnetic fields to non-invasively stimulate the brain. Studies overseas have suggested this may be an effective and safe treatment for auditory hallucinations in patients with schizophrenia. This is a sham-controlled, double-blind trial of TMS stimulation for the treatment of auditory hallucinations in patients with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_1

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

September 1, 1999

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
Last Updated

January 20, 2010

Status Verified

November 1, 2009

Enrollment Period

9 years

First QC Date

September 30, 2008

Last Update Submit

January 19, 2010

Conditions

Auditory Hallucinations

Keywords

Auditory hallucinations

Outcome Measures

Primary Outcomes (1)

  • Daily Voices Ratings (Mental Health Research Institute, Victoria)

    Daily

Study Arms (2)

1

EXPERIMENTAL

Stimulation will be given daily at a particular site for three days a week

Device: Transcranial magnetic stimulation

2

SHAM COMPARATOR
Device: Sham

Interventions

Transcranial magnetic stimulationDEVICE

Stimulation will be given daily at a particular site for three days a week

1
ShamDEVICE
2

Eligibility Criteria

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

You may qualify if:

  • Over 18, with DSM-IV diagnosis of Schizophrenia and auditory hallucinations of clear external origins, refractory to pharmacotherapy and occurring at least 5 times per day.

You may not qualify if:

  • Subjects with contraindications to TMS (e.g. epilepsy, pacemaker) or those with an unacceptably high risk (e.g. suicide risk) will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Psychiatry

Sydney, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Hallucinations

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Colleen Loo, MBBS, FRANZCP. MD

    University of NSW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

September 1, 1999

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 20, 2010

Record last verified: 2009-11

Locations

AU(1)