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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04140773
Other study ID # 2019-01699
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 25, 2021
Est. completion date August 31, 2022

Study information

Verified date September 2022
Source Psychiatric Hospital of the University of Basel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
D-serine
Capsule D-serine
Other:
Placebo
Capsule D-serine

Locations

Country Name City State
Switzerland UPK Basel Basel Basel-Stadt

Sponsors (1)

Lead Sponsor Collaborator
Dragos Inta

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Symptom severity and treatment response measured with the Clinical Global Impression Scale (CGI), lower scores indicate a better outcome change from baseline to 6 weeks
Secondary 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
Secondary Mismatch Negativity (MMN) measured with EEG change from baseline to 6 weeks
Secondary Intelligence Part of neurocognitive testing. Higher scores indicate better outcome. change from baseline to 6 weeks
Secondary Attention and processing speed Part of neurocognitive testing. Higher scores indicate better outcome. change from baseline to 6 weeks
Secondary Executive functioning Part of neurocognitive testing. Higher scores indicate better outcome. change from baseline to 6 weeks
Secondary Memory Part of neurocognitive testing. Higher scores indicate better outcome. change from baseline to 6 weeks
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