Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - Full Text View

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia (RESIS)

This study is currently recruiting participants.

Verified by Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH, November 2008

Sponsors and Collaborators:	Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH Dept. of Psychiatry and Psychotherapy University Hospital of the Georg-August-University Göttingen von-Siebold-Str. 5 37075 Göttingen
Information provided by:	Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH
ClinicalTrials.gov Identifier:	NCT00783120

Purpose

Schizophrenia is a major psychotic disorder that presents an enormous burden to the patients and their relatives. Despite treatment with second generation antipsychotics, negative symptoms and cognitive impairment often persist and determine an unfavourable course including reduction in life quality. Prefrontal repetitive transcranial magnetic stimulation (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing antipsychotic treatment was demonstrated to be safe and was associated with improvement in negative symptoms in the majority of the small placebo-controlled trials.

The primary objective of the trial is to investigate the efficacy of high-frequency rTMS (add-on to antipsychotic therapy) in the treatment of negative symptoms in schizophrenia compared to sham stimulation (placebo).

Condition	Intervention
Schizophrenia	Other: Repetitive transcranial magnetic stimulation Other: Sham repetitive transcranial magnetic stimulation

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - a Multicenter Study

Further study details as provided by Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH:

Primary Outcome Measures:

Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score) [ Time Frame: 105 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function [ Time Frame: 105 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold).	Other: Repetitive transcranial magnetic stimulation 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold); in total 15.000 stimuli.
2: Sham Comparator placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session)	Other: Sham repetitive transcranial magnetic stimulation placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female in-patients and out-patients, 18 - 60 years of age
Diagnostic criteria for schizophrenia according to ICD-10/DSM IV
PANSS negative sum score > 20 points, 1 of items N1 - N7 (range 1 to 7) ≥ 4 (at least moderate)
Improvement in PANSS negative sum score less than 10 % in the last 2 weeks prior to study entry, stable antipsychotic medication
Informed Consent

Exclusion Criteria:

Clinically relevant psychiatric comorbidity, verbal IQ < 85
History of epileptic seizures, organic brain disease
Instable medical comorbidity or condition
Previous treatment by rTMS
Factors not compatible with the use of TMS, e.g. cardiac pace makers or other metallic implants, pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783120

Contacts

Contact: Peter G. Falkai, Prof. MD.	+49 (0) 551-39-66 01	pfalkai@gwgd.de
Contact: Thomas Wobrock, MD.	+49 (0) 551-39-9667	twobroc@gwdg.de

Locations

Germany, Bayern
Department of Psychiatry and Psychotherapy, University of Regensburg	Recruiting
Regensburg, Bayern, Germany, 93053
Contact: Goeran Hajak, Prof MD. +49 (0)941 941 2011 goeran.hajak@medbo.de
Contact: Peter Eichhammer, Prof MD. +49-941-9412056 peter.eichhammer@medbo.de
Principal Investigator: Goeran Hajak, Prof MD.
Sub-Investigator: Peter Eichhammer, Prof MD.
Sub-Investigator: Berthold Langguth, Dr MD.
Germany, Niedersachsen
Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen	Recruiting
Goettingen, Niedersachsen, Germany, 37075
Contact: Peter G. Falkai, Prof. MD +49 (0) 551-39-66 01 pfalkai@gwgd.de
Contact: Thomas Wobrock, MD. +49 (0) 551-39-9667 twobroc@gwdg.de
Principal Investigator: Thomas Wobrock, MD.
Germany, Nordrhein-Westfalen
Department of Psychiatry, Heinrich-Heine University Hospital	Recruiting
Duesseldorf, Nordrhein-Westfalen, Germany, 40629
Contact: Joachim Cordees, MD. +49-(0)211-922-3402 joachim.cordes@lvr.de
Contact: Wolfgang Wölwer, PhD +49-211-922-2002 wolfgang.woelwer@uni-duesseldorf.de
Principal Investigator: Joachim Cordes, MD.
Sub-Investigator: Georg Winterer, Prof MD.

Sponsors and Collaborators

Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH

Dept. of Psychiatry and Psychotherapy

University Hospital of the Georg-August-University Göttingen

von-Siebold-Str. 5

37075 Göttingen

Investigators

Study Director:

Peter G Falkai, Prof MD.

Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen

More Information

Responsible Party:	Dept. of Psychiatry and Psychotherapy ( Prof. MD. Peter Falkai )
Study ID Numbers:	RESIS
Study First Received:	October 30, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00783120
Health Authority:	Germany: Ethics Commission

Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH:

schizophrenia, negative symptoms, TMS, magnetic stimulation

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009