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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sham repetitive transcranial magnetic stimulation
Sponsored by
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, negative symptoms, TMS, magnetic stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University of Regensburg
  • Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
  • Department of Psychiatry, Heinrich-Heine University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

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).

placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session)

Outcomes

Primary Outcome Measures

Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)

Secondary Outcome Measures

efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function

Full Information

First Posted
October 30, 2008
Last Updated
November 1, 2013
Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborators
University of Göttingen
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1. Study Identification

Unique Protocol Identification Number
NCT00783120
Brief Title
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia
Acronym
RESIS
Official Title
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - a Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborators
University of Göttingen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, negative symptoms, TMS, magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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).
Arm Title
2
Arm Type
Sham Comparator
Arm Description
placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session)
Intervention Type
Other
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham repetitive transcranial magnetic stimulation
Intervention Description
placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli
Primary Outcome Measure Information:
Title
Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)
Time Frame
105 Days
Secondary Outcome Measure Information:
Title
efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function
Time Frame
105 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter G Falkai, Prof MD.
Organizational Affiliation
Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Department of Psychiatry, Heinrich-Heine University Hospital
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40629
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28981875
Citation
Koutsouleris N, Wobrock T, Guse B, Langguth B, Landgrebe M, Eichhammer P, Frank E, Cordes J, Wolwer W, Musso F, Winterer G, Gaebel W, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Dwyer D, Ghaseminejad F, Dechent P, Malchow B, Kreuzer PM, Poeppl TB, Schneider-Axmann T, Falkai P, Hasan A. Predicting Response to Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia Using Structural Magnetic Resonance Imaging: A Multisite Machine Learning Analysis. Schizophr Bull. 2018 Aug 20;44(5):1021-1034. doi: 10.1093/schbul/sbx114.
Results Reference
derived
PubMed Identifier
27725655
Citation
Hasan A, Wobrock T, Guse B, Langguth B, Landgrebe M, Eichhammer P, Frank E, Cordes J, Wolwer W, Musso F, Winterer G, Gaebel W, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Dechent P, Malchow B, Castro MFU, Dwyer D, Cabral C, Kreuzer PM, Poeppl TB, Schneider-Axmann T, Falkai P, Koutsouleris N. Structural brain changes are associated with response of negative symptoms to prefrontal repetitive transcranial magnetic stimulation in patients with schizophrenia. Mol Psychiatry. 2017 Jun;22(6):857-864. doi: 10.1038/mp.2016.161. Epub 2016 Oct 11.
Results Reference
derived
PubMed Identifier
25582269
Citation
Wobrock T, Guse B, Cordes J, Wolwer W, Winterer G, Gaebel W, Langguth B, Landgrebe M, Eichhammer P, Frank E, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Malchow B, Schneider-Axmann T, Falkai P, Hasan A. Left prefrontal high-frequency repetitive transcranial magnetic stimulation for the treatment of schizophrenia with predominant negative symptoms: a sham-controlled, randomized multicenter trial. Biol Psychiatry. 2015 Jun 1;77(11):979-88. doi: 10.1016/j.biopsych.2014.10.009. Epub 2014 Oct 23.
Results Reference
derived
PubMed Identifier
19876678
Citation
Cordes J, Falkai P, Guse B, Hasan A, Schneider-Axmann T, Arends M, Winterer G, Wolwer W, Ben Sliman E, Ramacher M, Schmidt-Kraepelin C, Ohmann C, Langguth B, Landgrebe M, Eichhammer P, Frank E, Burger J, Hajak G, Rietschel M, Wobrock T. Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study. Eur Arch Psychiatry Clin Neurosci. 2009 Nov;259 Suppl 2:S189-97. doi: 10.1007/s00406-009-0060-y.
Results Reference
derived

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

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