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

NCT04140773 | Terminated

• 1 other identifier: 2019-01699
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Psychotic Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Subscales symptom severity

  change from baseline to 6 weeks

• Symptom severity and treatment response

  change from baseline to 6 weeks

• Resting-state microstates

  change from baseline to 6 weeks

• Mismatch Negativity (MMN)

  change from baseline to 6 weeks

• Intelligence

  change from baseline to 6 weeks

Study Arms (2)

D-serine group

EXPERIMENTAL

Oral administration of 2g D-serine per day, for 6 weeks.

Dietary Supplement: D-serine

Placebo group

PLACEBO COMPARATOR

Oral administration of 2g Placebo (Mannitol) per day, for 6 weeks.

Other: Placebo

Interventions

D-serine DIETARY_SUPPLEMENT

Capsule D-serine

D-serine group

Placebo OTHER

Capsule D-serine

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50
• Recent onset psychosis (\< 5 years of overt psychotic symptoms)
• Able to read and understand study procedures and participant's information

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dragos Inta: lead

Study Sites (1)

UPK Basel

Basel, Canton of Basel-City, 4002, Switzerland

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 28, 2019
• Study Start: November 25, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)