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Therapeutic Response and Neurobiological Prediction Markers in Auditory Verbal Hallucinations

Therapeutic Response and Neurobiological Prediction Markers in Auditory Verbal Hallucinations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00006849
Enrollment
140
Registered
2014-11-06
Start date
2015-02-19
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F20 F25 F23

Interventions

Group 1: A) Antipsychotic medicinal treatment as usual on the ward Group 2: B) 1Hz rTMS verum 20min./d on 10 days in non-medicated patients Group 3: D) rTMS sham 20min./d on 10 days in non-medicated

Sponsors

Translational Research Center, Division of Systems Neuroscience of Psychopathology, University Hospital of Psychiatry
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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.)

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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).

Countries

Switzerland

Contacts

Public ContactKatharina Kunzelmann

Translational Research Center, Division of Systems Neuroscience of Psychopathology, University Hospital of Psychiatry

katharina.kunzelmann@upd.unibe.ch+41319328707

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026