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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Other: Sham repetitive transcranial magnetic stimulation; Other: Repetitive transcranial magnetic stimulation

• Registration Number: NCT00783120
• Lead Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-01
• Last Update Posted: 2013-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Sham repetitive transcranial magnetic stimulation	placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session)
1	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).

Primary Outcome Measures

Name	Time	Method
Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)	105 Days

Secondary Outcome Measures

Name	Time	Method
efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function	105 days

Trial Locations

Locations (3)

Department of Psychiatry, Heinrich-Heine University Hospital; 🇩🇪 Duesseldorf, Nordrhein-Westfalen, Germany

Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen; 🇩🇪 Goettingen, Niedersachsen, Germany

Department of Psychiatry and Psychotherapy, University of Regensburg; 🇩🇪 Regensburg, Bayern, Germany