eural and behavioral markers for the motivational negative symptoms of schizophrenia – a longitudinal approach
- Conditions
- F20F25SchizophreniaSchizoaffective disorders
- Registration Number
- DRKS00011405
- Lead Sponsor
- Charité - Universitätsmedizin BerlinKlinik für Psychiatrie und Psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 175
In order to be eligible to participate in this study, all participants must meet all of the following criteria:
• 18-60 years old
• Written informed consent
In patients the diagnostic criteria are:
• DSM-5 diagnosis of schizophrenia on the basis of the Structured Clinical Interview for DSM-5 (SCID-I)
• Clinical stability as judged by the treating psychiatrist and indicated by no change in medication in the two weeks prior to the initial assessment
Any potential subject who meets any of the following criteria will be excluded from participation in this study:
• Any previous neurosurgery or neurological disorder, including epilepsy
• History of head injury resulting in unconsciousness lasting at least 1 hour
• Pregnancy or lactation
• Any contraindications for MRI such as ferromagnetic/non-MRI-compatible items or medical devices on or in the body (for example pacemaker, brain stimulator, clips, metal implants)
• sensorineural hearing loss of 30dB or more or history of tinnitus
• Incompetency to fully comprehend the purpose of the study or to make a rational decision whether or not to participate
In patients additional exclusion criteria are:
• Benzodiazepine use of more than 1mg lorazepam equivalents per day
• Comorbid axis-I disorder
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Strength of association between neural and behavorial markers with motivational negative symptoms<br><br>
- Secondary Outcome Measures
Name Time Method (1)The association between the neurobehavioral marker and apathy is reproducible across centers.<br>(2)The association between the neurobehavioral marker and apathy is stable over the time of 3 months.<br>(3) The neurobehavioral marker at the initial assessment will predict the level of negative symptoms 9 months later.