The Effect of D-serine as add-on Therapy in Recent-onset Psychosis

Psychotic Disorder Clinical Trial

— DROP  

Official title:

The Effect of D-serine as add-on Therapy in Recent-onset Psychosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04140773
• Other study ID #: 2019-01699
• Status: Terminated
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorder
• Psychotic Disorders

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