Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - a Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Enrollment
- 197
- Locations
- 3
- Primary Endpoint
- Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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).
Investigators
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
Outcomes
Primary Outcomes
Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)
Time Frame: 105 Days
Secondary Outcomes
- efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function(105 days)