Psychotic Disorder
Conditions
Brief summary
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
Interventions
DIETARY_SUPPLEMENTD-serine
Capsule D-serine
OTHERPlacebo
Capsule D-serine
Sponsors
Dragos Inta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-50 * Recent onset psychosis (\< 5 years of overt psychotic symptoms) * Able to read and understand study procedures and participant's information
Exclusion criteria
* Clozapine use * Suicidal ideation * Psychotic disorders and symptoms associated with general medical conditions or substance abuse * BMI \> 30 * Renal impairment (history and creatin levels (\< 80 ug/L for woman and \< 97 ug/L for men)) * Hearing impairment * Current or past (\< 6 months) enrolment in another clinical trial with the primary outcome to improve symptoms * Pregnant or lactating women (pregnancy test)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total symptom severity | change from baseline to 6 weeks | total score on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome (min. 30 - max. 120). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom severity and treatment response | change from baseline to 6 weeks | measured with the Clinical Global Impression Scale (CGI), lower scores indicate a better outcome |
| Resting-state microstates | change from baseline to 6 weeks | 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. |
| Mismatch Negativity (MMN) | change from baseline to 6 weeks | measured with EEG |
| Subscales symptom severity | change from baseline to 6 weeks | Subscores (5-factor model) on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome. |
| Attention and processing speed | change from baseline to 6 weeks | Part of neurocognitive testing. Higher scores indicate better outcome. |
| Executive functioning | change from baseline to 6 weeks | Part of neurocognitive testing. Higher scores indicate better outcome. |
| Memory | change from baseline to 6 weeks | Part of neurocognitive testing. Higher scores indicate better outcome. |
| Intelligence | change from baseline to 6 weeks | Part of neurocognitive testing. Higher scores indicate better outcome. |
Countries
Switzerland
Outcome results
None listed