RESIS: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 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.
|
| Sham Comparator: 2 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
|
Outcome Measures
Primary Outcome Measures
- Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score) [105 Days]
Secondary Outcome Measures
- efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function [105 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female in-patients and out-patients, 18 - 60 years of age
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Diagnostic criteria for schizophrenia according to ICD-10/DSM IV
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PANSS negative sum score > 20 points, 1 of items N1 - N7 (range 1 to 7) ≥ 4 (at least moderate)
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Improvement in PANSS negative sum score less than 10 % in the last 2 weeks prior to study entry, stable antipsychotic medication
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Informed Consent
Exclusion Criteria:
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Clinically relevant psychiatric comorbidity, verbal IQ < 85
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History of epileptic seizures, organic brain disease
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Instable medical comorbidity or condition
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Previous treatment by rTMS
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Factors not compatible with the use of TMS, e.g. cardiac pace makers or other metallic implants, pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Psychiatry and Psychotherapy, University of Regensburg | Regensburg | Bayern | Germany | 93053 |
| 2 | Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen | Goettingen | Niedersachsen | Germany | 37075 |
| 3 | Department of Psychiatry, Heinrich-Heine University Hospital | Duesseldorf | Nordrhein-Westfalen | Germany | 40629 |
Sponsors and Collaborators
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- University of Göttingen
Investigators
- Study Director: Peter G Falkai, Prof MD., Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RESIS