NCT00783120

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 4, 2013

Status Verified

November 1, 2013

Enrollment Period

3.6 years

First QC Date

October 30, 2008

Last Update Submit

November 1, 2013

Conditions

Schizophrenia

Keywords

schizophrenia, negative symptoms, TMS, magnetic stimulation

Outcome Measures

Primary Outcomes (1)

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

    105 Days

Secondary Outcomes (1)

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

    105 days

Study Arms (2)

1

EXPERIMENTAL

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).

Other: Repetitive transcranial magnetic stimulation

2

SHAM COMPARATOR

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

Other: Sham repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulationOTHER

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.

1
Sham repetitive transcranial magnetic stimulationOTHER

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

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, Bavaria, 93053, Germany

Location

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

Göttingen, Lower Saxony, 37075, Germany

Location

Department of Psychiatry, Heinrich-Heine University Hospital

Düsseldorf, North Rhine-Westphalia, 40629, Germany

Location

Related Publications (4)

  • Koutsouleris N, Wobrock T, Guse B, Langguth B, Landgrebe M, Eichhammer P, Frank E, Cordes J, Wolwer W, Musso F, Winterer G, Gaebel W, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Dwyer D, Ghaseminejad F, Dechent P, Malchow B, Kreuzer PM, Poeppl TB, Schneider-Axmann T, Falkai P, Hasan A. Predicting Response to Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia Using Structural Magnetic Resonance Imaging: A Multisite Machine Learning Analysis. Schizophr Bull. 2018 Aug 20;44(5):1021-1034. doi: 10.1093/schbul/sbx114.

    PMID: 28981875DERIVED

  • Hasan A, Wobrock T, Guse B, Langguth B, Landgrebe M, Eichhammer P, Frank E, Cordes J, Wolwer W, Musso F, Winterer G, Gaebel W, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Dechent P, Malchow B, Castro MFU, Dwyer D, Cabral C, Kreuzer PM, Poeppl TB, Schneider-Axmann T, Falkai P, Koutsouleris N. Structural brain changes are associated with response of negative symptoms to prefrontal repetitive transcranial magnetic stimulation in patients with schizophrenia. Mol Psychiatry. 2017 Jun;22(6):857-864. doi: 10.1038/mp.2016.161. Epub 2016 Oct 11.

    PMID: 27725655DERIVED

  • Wobrock T, Guse B, Cordes J, Wolwer W, Winterer G, Gaebel W, Langguth B, Landgrebe M, Eichhammer P, Frank E, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Malchow B, Schneider-Axmann T, Falkai P, Hasan A. Left prefrontal high-frequency repetitive transcranial magnetic stimulation for the treatment of schizophrenia with predominant negative symptoms: a sham-controlled, randomized multicenter trial. Biol Psychiatry. 2015 Jun 1;77(11):979-88. doi: 10.1016/j.biopsych.2014.10.009. Epub 2014 Oct 23.

    PMID: 25582269DERIVED

  • Cordes J, Falkai P, Guse B, Hasan A, Schneider-Axmann T, Arends M, Winterer G, Wolwer W, Ben Sliman E, Ramacher M, Schmidt-Kraepelin C, Ohmann C, Langguth B, Landgrebe M, Eichhammer P, Frank E, Burger J, Hajak G, Rietschel M, Wobrock T. Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study. Eur Arch Psychiatry Clin Neurosci. 2009 Nov;259 Suppl 2:S189-97. doi: 10.1007/s00406-009-0060-y.

    PMID: 19876678DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Peter G Falkai, Prof MD.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2008

First Posted

October 31, 2008

Study Start

January 1, 2008

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

November 4, 2013

Record last verified: 2013-11

Locations

DE(3)