Therapeutic Response and Neurobiological Prediction Markers in Auditory Verbal Hallucinations

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00006849
• Date of registration: 06/11/2014
• Prospective Registration: Yes
• Primary sponsor: Translational Research Center, Division of Systems Neuroscience of Psychopathology, University Hospital of Psychiatry
• Public title: Therapeutic Response and Neurobiological Prediction Markers in Auditory Verbal Hallucinations
• Scientific title: Therapeutic Response and Neurobiological Prediction Markers in Auditory Verbal Hallucinations
• Date of first enrolment: 19/02/2015
• Target sample size: 140
• Recruitment status: Recruiting stopped after recruiting started
• URL: http://drks.de/search/en/trial/DRKS00006849
• Study type: interventional
• Study design: Allocation: Non-randomized controlled study; Masking: Blinded (masking used); Control: active//placebo; Assignment: parallel; Study design purpose: basic science
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Katharina Kunzelmann
• Affiliation: Translational Research Center, Division of Systems Neuroscience of Psychopathology, University Hospital of Psychiatry

• Name: Thomas Dierks
• Affiliation: Translational Research Center, Division of Systems Neuroscience of Psychopathology, University Hospital of Psychiatry

Key inclusion & exclusion 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: • 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


Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

F20
F25
F23

Acute and transient psychotic disorders

Schizoaffective disorders

Schizophrenia

Intervention(s)

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 patients
Group 4: C) 2mA tDCS verum 20min. 2 times/d on 5 days
in non-medicated patients
Group 5: E) tDCS sham 20min. 2 times/d on 5 days in non-medicated patients
Group 6: F) 2mA tDCS verum 20min. 2 times/d on 5 days
in medicated patients
Group 7: G) tDCS sham 20min. 2 times/d on 5 days in medicated patients

Primary Outcome(s)

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(s)

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).

Source(s) of Monetary Support

Schweizerischer Nationalfonds (SNF)

Ethics review

Status: Approved
Approval date: 23/06/2014
Contact:

Kantonale Ethikkommission Bern (KEK) [Kanthonale Ethikkommission Bern]

Results

• Date Completed: 30/06/2018
• URL: http://drks.de/search/en/trial/DRKS00006849#studyResults