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

Primary Purpose

Psychotic Disorder

Status

Terminated

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

D-serine

Placebo

About this trial

This is an interventional treatment trial for Psychotic Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

UPK Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

D-serine group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total symptom severity

total score on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome (min. 30 - max. 120).

Secondary Outcome Measures

Subscales symptom severity

Subscores (5-factor model) on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome.

Symptom severity and treatment response

measured with the Clinical Global Impression Scale (CGI), lower scores indicate a better outcome

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.

Mismatch Negativity (MMN)

measured with EEG

Intelligence

Part of neurocognitive testing. Higher scores indicate better outcome.

Attention and processing speed

Part of neurocognitive testing. Higher scores indicate better outcome.

Executive functioning

Part of neurocognitive testing. Higher scores indicate better outcome.

Memory

Part of neurocognitive testing. Higher scores indicate better outcome.

Full Information

NCT ID

NCT04140773

First Posted

October 18, 2019

Last Updated

September 6, 2022

Sponsor

Dragos Inta

1. Study Identification

Unique Protocol Identification Number

NCT04140773

Brief Title

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

Acronym

DROP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Terminated

Why Stopped

Poor participant recruitment

Study Start Date

November 25, 2021 (Actual)

Primary Completion Date

August 31, 2022 (Actual)

Study Completion Date

August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dragos Inta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychotic Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

D-serine group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

D-serine

Intervention Description

Capsule D-serine

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Capsule D-serine

Primary Outcome Measure Information:

Title

Total symptom severity

Description

total score on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome (min. 30 - max. 120).

Time Frame

change from baseline to 6 weeks

Secondary Outcome Measure Information:

Title

Subscales symptom severity

Description

Subscores (5-factor model) on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome.

Time Frame

change from baseline to 6 weeks

Title

Symptom severity and treatment response

Description

measured with the Clinical Global Impression Scale (CGI), lower scores indicate a better outcome

Time Frame

change from baseline to 6 weeks

Title

Resting-state microstates

Description

Time Frame

change from baseline to 6 weeks

Title

Mismatch Negativity (MMN)

Description

measured with EEG

Time Frame

change from baseline to 6 weeks

Title

Intelligence

Description

Part of neurocognitive testing. Higher scores indicate better outcome.

Time Frame

change from baseline to 6 weeks

Title

Attention and processing speed

Description

Part of neurocognitive testing. Higher scores indicate better outcome.

Time Frame

change from baseline to 6 weeks

Title

Executive functioning

Description

Part of neurocognitive testing. Higher scores indicate better outcome.

Time Frame

change from baseline to 6 weeks

Title

Memory

Description

Part of neurocognitive testing. Higher scores indicate better outcome.

Time Frame

change from baseline to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

UPK Basel

City

Basel

State/Province

Basel-Stadt

ZIP/Postal Code

4002

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

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

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