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Completed

NCT Number: NCT00783120

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

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).

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation

Other

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 repetitive transcranial magnetic stimulation

Other

placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli

Primary outcomes

  1. Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)

    Time frame: 105 Days

Secondary outcomes

  1. efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function

    Time frame: 105 days

Sponsors and collaborators

Lead sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Other

Collaborators

  • University of Göttingen

Registry information

Official study title

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - a Multicenter Study

Acronym: RESIS

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 31, 2008
Registry last updated
Nov 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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