The Effect of D-serine as add-on Therapy in Recent-onset Psychosis
- Conditions
- Psychotic Disorder
- Interventions
- Other: PlaceboDietary Supplement: D-serine
- Registration Number
- NCT04140773
- Lead Sponsor
- Dragos Inta
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- Age 18-50
- Recent onset psychosis (< 5 years of overt psychotic symptoms)
- Able to read and understand study procedures and participant's information
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo Oral administration of 2g Placebo (Mannitol) per day, for 6 weeks. D-serine group D-serine Oral administration of 2g D-serine per day, for 6 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Executive functioning change from baseline to 6 weeks Part of neurocognitive testing. Higher scores indicate better outcome.
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.
Mismatch Negativity (MMN) change from baseline to 6 weeks measured with EEG
Attention and processing speed 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.
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.Intelligence change from baseline to 6 weeks Part of neurocognitive testing. Higher scores indicate better outcome.
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
Trial Locations
- Locations (1)
UPK Basel
🇨ðŸ‡Basel, Basel-Stadt, Switzerland