Therapeutic Response and Neurobiological Prediction Markers in Auditory Verbal Hallucinations

Not Applicable

• Conditions: F20; F25; F23; Schizophrenia; Schizoaffective disorders; Acute and transient psychotic disorders

• Registration Number: DRKS00006849
• Lead Sponsor: Translational Research Center, Division of Systems Neuroscience of Psychopathology, University Hospital of Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-06
• Study Completion: 2018-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 12

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

• 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.<br>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).