A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Assoc Professor Paul Fitzgerald, The Alfred

ClinicalTrials.gov Identifier:

NCT00168311

First received: September 14, 2005

Last updated: April 15, 2012

Last verified: April 2012

History of Changes

Results First Received: June 15, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Schizophrenia
Interventions:	Device: Transcranial Magnetic Stimulation Device: sham TMS

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 20 patients were randomly assigned. Patients were recruited from the outpatient department of two public area mental health services and by referral from a number of private psychiatrists between January 2003 and July 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Active Treatment	Bilateral high frequency (10Hz) rTMS
Sham Treatment	Sham bilateral rTMS treatment

Participant Flow: Overall Study

	Active Treatment	Sham Treatment
STARTED	12	10
COMPLETED	12	8
NOT COMPLETED	0	2

Baseline Characteristics

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Reporting Groups

	Description
Active Treatment	Bilateral high frequency (10Hz) rTMS
Sham Treatment	Sham bilateral rTMS treatment
Total	Total of all reporting groups

Baseline Measures

	Active Treatment	Sham Treatment	Total
Number of Participants [units: participants]	12	10	22
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	12	10	22
>=65 years	0	0	0
Gender ^[1] [units: participants]
Female	2	2	4
Male	10	8	18
Region of Enrollment [units: participants]
Australia	12	10	22

[1]	16 men and 4 women

Outcome Measures

1. Primary:

Scale for the Asessment of Negative Symptoms (SANS) [ Time Frame: 3 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Insufficient time period used to be able to establish a substantive therapeutic effect of rTMS; standard dosing method may be inadequate due to volumetric changes in brain regions in schizophrenia; concurrent antipsychotic medication.

Results Point of Contact:

Name/Title: Professor Paul Fitzgerald
Organization: Monash Alfred Psychiatry Research Centre
phone: +61 3 9076 6564
e-mail: p.fitzgerald@alfred.org.au

No publications provided

Responsible Party:	Assoc Professor Paul Fitzgerald, The Alfred
ClinicalTrials.gov Identifier:	NCT00168311 History of Changes
Other Study ID Numbers:	81/02
Study First Received:	September 14, 2005
Results First Received:	June 15, 2010
Last Updated:	April 15, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

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