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Poor participant recruitment
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-serine group | Experimental | Oral administration of 2g D-serine per day, for 6 weeks. |
|
| Placebo group | Placebo Comparator | Oral administration of 2g Placebo (Mannitol) per day, for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-serine | Dietary Supplement | Capsule D-serine |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Total symptom severity | total score on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome (min. 30 - max. 120). | change from baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subscales symptom severity | Subscores (5-factor model) on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome. | change from baseline to 6 weeks |
| Symptom severity and treatment response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPK Basel | Basel | Canton of Basel-City | 4002 | Switzerland |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Other |
Capsule D-serine |
|
measured with the Clinical Global Impression Scale (CGI), lower scores indicate a better outcome
| 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. | change from baseline to 6 weeks |
| Mismatch Negativity (MMN) | measured with EEG | change from baseline to 6 weeks |
| Intelligence | Part of neurocognitive testing. Higher scores indicate better outcome. | change from baseline to 6 weeks |
| Attention and processing speed | Part of neurocognitive testing. Higher scores indicate better outcome. | change from baseline to 6 weeks |
| Executive functioning | Part of neurocognitive testing. Higher scores indicate better outcome. | change from baseline to 6 weeks |
| Memory | Part of neurocognitive testing. Higher scores indicate better outcome. | change from baseline to 6 weeks |