Trial document




drksid header

  DRKS00006849

Trial Description

start of 1:1-Block title

Title

Therapeutic Response and Neurobiological Prediction Markers in Auditory Verbal Hallucinations

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.stimme.be

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Auditory verbal hallucinations (AVH) are a very common symptom in schizophrenia. As a great part of patients are resistant to the treatment of AVH with antipsychotic drugs, alternative treatment regimen are needed. Transcranial magnetic stimulation (TMS) was shown to reduce AVH in medication-resistant patients and to decrease hyperactivity in the left superior temporal brain areas active during AVH. Additionally, only responders to TMS showed hyperactivity in these temporal areas, suggesting a potential prediction marker for treatment response. Although these results are promising, populations in earlier studies were small and recent results of a study with a greater population suggested no superiority of verum TMS treatment in comparison to sham treatment.
Furthermore, transcranial direct current stimulation (tDCS) was introduced as potential treatment method for AVH in patients. Again, patient samples were small but results were promising.
The present study aimes to examine the effects of TMS in non-medicated patients in comparison to antipsychotic medicinal treatment as usual and to compare the effects of tDCS in medicated vs. non-medicated patients. For this, an amendment of the ethics commission allowed to extend the study population by 40 additional medicated patients who are offered tDCS verum or sham stimulation.
An additional aim of the study is to detect potential neurobiological prediction markers for treatment response.
The study protocol consists of one week (tDCS stimulation) or two weeks (TMS stimulation) of treatment and pre/post examinations (EEG, fMRI and a clinical interview including PsyRats, other hallucination scales and scales for psychopathological symptoms). We plan to include 140 patients in the study.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006849
  •   2014/11/06
  •   [---]*
  •   yes
  •   Approved
  •   KEK 066/2014, Kanthonale Ethikkommission Bern
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   F25 -  Schizoaffective disorders
  •   F23 -  Acute and transient psychotic disorders
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   A) Antipsychotic medicinal treatment as usual on the ward
  •   B) 1Hz rTMS verum 20min./d on 10 days in non-medicated patients
  •   D) rTMS sham 20min./d on 10 days in non-medicated patients
  •   C) 2mA tDCS verum 20min. 2 times/d on 5 days
    in non-medicated patients
  •   E) tDCS sham 20min. 2 times/d on 5 days in non-medicated patients
  •   F) 2mA tDCS verum 20min. 2 times/d on 5 days
    in medicated patients
  •   G) tDCS sham 20min. 2 times/d on 5 days in medicated patients
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo, Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcome variable will be the score on the interview questions of the PsyRats (Psychotic Symptom Rating Scales) before treatment (baseline) and after treatment.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary outcomes will be the results of other hallucination and other scales for psychopathological measures (The Bern Psychopathology Scale, BPS; Auditory Hallucinations Rating Scale, AHRS; Positive and Negative Syndrome Scale, PANSS; Clinical Global Impression, CGI; Global Assessment Functioning, GAF), measured in advance of treatment (baseline) and right after treatment.
In addition, neurobiological changes caused by the treatment will be measured by imaging devices (MRI and EEG) before and after treatment. After every treatment session, potential side effects of stimulation and changes in quality of hallucinations will also be recorded by a side effect questionnaire and the Hallucination Change Scale (HCS).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/02/19
  •   140
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• ICD-10: patients of the University Hospital of Psychiatry in Bern with schizophrenia (F20), acute and transient psychotic disorder (F23), or schizoaffective disorder (F25), prone to AVH in the acute phases of the disorder
• Patients not declining conventional antipsychotic treatment (Treatment arms A, F, G) or patients declining conventional antipsychotic treatment (Treatment arm B-E)
• Right-handedness
• Able to give informed written consent to participate in the study and ability to follow the procedures of the study (no language problems, psychological disorders, dementia, etc.)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• Involuntary commitment (individuals with symptoms of severe mental illness endangering themselves or others are committed into treatment in a hospital)
• Other psychiatric or neurological disorder than F20 or F25
• Skin disease on the head
• Participation in other clinical studies
• Non-removable metallic components (splinters, cardiac pacemakers, metal clips, metal implants, cochlear-implants, insulin pumps, etc.)
• Tattoos on or near the head
• Permanent make-up
• Claustrophobia
• Signs of increased cerebral excitability (EEG)

For female patients:
• Pregnancy or breast feeding
• Intention to become pregnant during the course of the study
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Translational Research Center, Division of Systems Neuroscience of Psychopathology, University Hospital of Psychiatry
    • Mr.  Prof. Dr. med.  Thomas  Dierks 
    • Bolligenstrasse 111
    • 3000  Bern 60
    • Switzerland
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Translational Research Center, Division of Systems Neuroscience of Psychopathology, University Hospital of Psychiatry
    • Mr.  Prof. Dr. med.  Thomas  Dierks 
    • Bolligenstrasse 111
    • 3000  Bern 60
    • Switzerland
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Translational Research Center, Division of Systems Neuroscience of Psychopathology, University Hospital of Psychiatry
    • Ms.  Dr.  Katharina  Kunzelmann 
    • Bolligenstrasse 111
    • 3000  Bern 60
    • Switzerland
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Schweizerischer Nationalfonds (SNF)
    • Wildhainweg 3/Postfach 8232
    • 3001  Bern
    • Switzerland
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting stopped after recruiting started
  •   2018/06/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.