In psychotic disorders, negative symptoms and cognitive impairment are difficult to treat with antipsychotics, which are mostly effective for positive symptoms. However, it is important that negative symptoms and cognitive impairment are treated as well, as they both play a large part in the acute episode and long-term course of schizophrenia outcome. Previous studies have used D-serine as add-on treatment in patients with psy-chotic disorders and high-risk patients, with positive results. So far, no study has investigated the effects in a sample of recent-onset psychosis patients. Therefore, this study will include 30 patients (18-50 years old) with recent-onset psychosis. In addition to their regular treatment, patients will receive either D-serine (2 g/d) or placebo for 6 weeks. D-serine is an amino-acid naturally occurring in the brain which is prescription-free available as nutritional supplement. The primary outcome measure is total score on the Positive and Negative Syndrome Scale (PANSS). Secondary measure-ments include PANSS subscales, neurocognitive tests, (f)MRI, and EEG
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3
Capsule D-serine
Capsule D-serine
UPK Basel
Basel, Canton of Basel-City, Switzerland
Total symptom severity
total score on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome (min. 30 - max. 120).
Time frame: change from baseline to 6 weeks
Subscales symptom severity
Subscores (5-factor model) on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome.
Time frame: change from baseline to 6 weeks
Symptom severity and treatment response
measured with the Clinical Global Impression Scale (CGI), lower scores indicate a better outcome
Time frame: change from baseline to 6 weeks
Resting-state microstates
measured with resting-state electroencephalography (EEG). large-scale neural networks are investigated with EEG microstates Ocillations in the theta-band (4-7 Hz) and gamma-band (\>30 Hz) will be assessed. measured with resting-state electroencephalography (EEG). Ocillations in the theta-band (4-7 Hz) and gamma-band (\>30 Hz) will be assessed.
Time frame: change from baseline to 6 weeks
Mismatch Negativity (MMN)
measured with EEG
Time frame: change from baseline to 6 weeks
Intelligence
Part of neurocognitive testing. Higher scores indicate better outcome.
Time frame: change from baseline to 6 weeks
Attention and processing speed
Part of neurocognitive testing. Higher scores indicate better outcome.
Time frame: change from baseline to 6 weeks
Executive functioning
Part of neurocognitive testing. Higher scores indicate better outcome.
Time frame: change from baseline to 6 weeks
Memory
Part of neurocognitive testing. Higher scores indicate better outcome.
Time frame: change from baseline to 6 weeks
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