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

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH197 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

197

Conditions

Schizophrenia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (3)

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, Bavaria, Germany

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

Göttingen, Lower Saxony, Germany

Department of Psychiatry, Heinrich-Heine University Hospital

Düsseldorf, North Rhine-Westphalia, Germany

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

Time frame: 105 days