Treatment of Auditory Hallucinations in Schizophrenia With Bilateral Theta Burst Stimulatio
- Conditions
- Auditory Hallucinations in the context of a schizophrenic diseaseDSM-5 295.90: Schizophrenia DisorderDSM-5295.40: Schizophreniform DisorderDSM-5 295.70: Schizoaffective Disorder
- Registration Number
- DRKS00014313
- Lead Sponsor
- niversitätsklinikum Tübingen, Klinik für Psychiatrie und Psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 86
Men and women, age 18-55 years
- Schizophrenia (DSM-5 295.90), schizophreniform disorder (DSM-5, 295.40), or schizoaffective disorder (DSM-5 295.70)
- Auditory hallucinations (AH) present at least once a week, for at least 3 months
- No sufficient effect of at least one adequate antipsychotic treatment
- Severity according to PANSS hallucination score (Item P3) of 3 or more
- Fluent German language
- Stable antipsychotic medication 4 weeks before and 3 weeks during the treatment.
Participants must have the capacity of consent and must be able to understand the subject information, to carry out the necessary examinations and appointments, and to declare consent after written and individual information has been provided.
The ability to give consent is checked by a physician who is not involved in the study.
- Suicidality
- History/evidence of brain surgery
- Significant brain malformation or neoplasm
- Head injury
- Cerebral vascular events
- Neurodegenerative disorder
- Deep brain stimulation
- Intracranial metallic particles
- History of seizures
- Diagnose of substance dependence or abuse as primary clinical problem
- Severe somatic comorbidity
- Cardiac pacemakers
- Pregnancy
- antiepileptic drugs and benzodiazepines corresponding to a dose of > 1 mg lorazepam per day
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Change of Psychotic Symptom Rating Scales - Auditory Hallucinations subscale (PSYRATS-AH); time frame: 3 weeks; Group comparison (active vs. sham cTBS) regarding the change of the auditory hallucination subscale of the Psychotic Symptom Rating Scales (PSYRATS-AH) score from baseline to end of treatment period.<br>
- Secondary Outcome Measures
Name Time Method Maintenance of therapy effects 1, 3, and 6 months after end of stimulation period; change of general psychopathological condition (PANSS, GAF, CGI)