SchizophreniaRESISNCT00783120
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia
A study testing Repetitive transcranial magnetic stimulation in people with Schizophrenia, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Germany3 sites
Department of Psychiatry, Heinrich-Heine University Hospital
Düsseldorf, North Rhine-Westphalia, 40629
Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
Göttingen, Lower Saxony, 37075
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, Bavaria, 93053
About this study
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - a Multicenter Study
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).
- Conditions
- Schizophrenia
- Being tested
- Repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
- Keywords
- schizophrenia, negative symptoms, TMS, magnetic stimulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham repetitive transcranial magnetic stimulationOther
placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Repetitive transcranial magnetic stimulation |
| 2 | Sham comparator | placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session) Receives: Other: Sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)
Measured: 105 Days
Secondary outcomes (1)
efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function
Measured: 105 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University of Göttingen
- Investigators
- Peter G Falkai, Prof MD., Study director, Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783120
- Sponsor's protocol ID
- RESIS
- Acronym
- RESIS
- Status last verified
- Nov 2013
- First submitted
- 30 Oct 2008
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28981875Hasan 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.
PubMed 27725655Wobrock 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.
PubMed 25582269Cordes 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.
PubMed 19876678
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - a Multicenter Study
- ClinicalTrials.gov ID
- NCT00783120
- Acronym / sponsor ID
- RESIS / RESIS
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, negative symptoms, TMS, magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbHUniversity, hospital or other
- Collaborators
- University of Göttingen
- Study start
- Jan 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Repetitive transcranial magnetic stimulation10 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). |
| 2 | Sham comparator | Other: Sham repetitive transcranial magnetic stimulationplacebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulation10 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. | Other | 1 |
| Sham repetitive transcranial magnetic stimulationplacebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli | Other | 2 |
Primary outcome
Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)
Time frame: 105 Days
1 secondary outcome
efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function
Time frame: 105 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
- Derived from this study: PubMed 28981875Koutsouleris 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.
- Derived from this study: PubMed 27725655Hasan 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.
- Derived from this study: PubMed 25582269Wobrock 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.
- Derived from this study: PubMed 19876678Cordes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter G Falkai, Prof MD. study director
Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Schizophrenia, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score) (time frame: 105 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00783120, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2013.