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

Institut für anwendungsorientierte Forschung und klinische Studien

Status: Completed

Conditions: Schizophrenia

Treatments: Other: Repetitive transcranial magnetic stimulation; Other: Sham repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00783120

RESIS

Details and patient eligibility

About

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).

Enrollment: 197 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

197 participants in 2 patient groups

1

Experimental group

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).

Treatment:

Other: Repetitive transcranial magnetic stimulation

2

Sham Comparator group

Description:

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

Treatment:

Other: Sham repetitive transcranial magnetic stimulation