Psychotic DisorderDROPNCT04140773
The Effect of D-serine as add-on Therapy in Recent-onset Psychosis
A study testing D-serine in people with Psychotic Disorder, run by Dragos Inta at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Psychotic Disorder
- What is being tested?
- D-serine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Nov 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50
- Recent onset psychosis (< 5 years of overt psychotic symptoms)
- Able to read and understand study procedures and participant's information
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- D-serine, Placebo
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-serineDietary supplement
Capsule D-serine
PlaceboOther
Capsule D-serine
| Study group | Role | What they receive |
|---|---|---|
| D-serine group | Experimental | Oral administration of 2g D-serine per day, for 6 weeks. Receives: Dietary Supplement: D-serine |
| Placebo group | Placebo comparator | Oral administration of 2g Placebo (Mannitol) per day, for 6 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total symptom severity
total score on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome (min. 30 - max. 120).
Measured: change from baseline to 6 weeks
Secondary outcomes (8)
Subscales symptom severity
Subscores (5-factor model) on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome.
Measured: change from baseline to 6 weeks
Symptom severity and treatment response
measured with the Clinical Global Impression Scale (CGI), lower scores indicate a better outcome
Measured: change from baseline to 6 weeks
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.
Measured: change from baseline to 6 weeks
Mismatch Negativity (MMN)
measured with EEG
Measured: change from baseline to 6 weeks
Intelligence
Part of neurocognitive testing. Higher scores indicate better outcome.
Measured: change from baseline to 6 weeks
Attention and processing speed
Part of neurocognitive testing. Higher scores indicate better outcome.
Measured: change from baseline to 6 weeks
Executive functioning
Part of neurocognitive testing. Higher scores indicate better outcome.
Measured: change from baseline to 6 weeks
Memory
Part of neurocognitive testing. Higher scores indicate better outcome.
Measured: change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start25 Nov 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Why it stopped: Poor participant recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dragos Inta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dragos Inta, Psychiatric Hospital of the University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140773
- Sponsor's protocol ID
- 2019-01699
- Other IDs
- 2019
- Acronym
- DROP
- Status last verified
- Sep 2022
- First submitted
- 18 Oct 2019
- Last updated
- 10 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of D-serine as add-on Therapy in Recent-onset Psychosis
- ClinicalTrials.gov ID
- NCT04140773
- Acronym / sponsor ID
- DROP / 2019-01699
- Conditions
- Psychotic Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor participant recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Dragos IntaUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-serine group | Experimental | Dietary Supplement: D-serineOral administration of 2g D-serine per day, for 6 weeks. |
| Placebo group | Placebo comparator | Other: PlaceboOral administration of 2g Placebo (Mannitol) per day, for 6 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-50
- Recent onset psychosis (< 5 years of overt psychotic symptoms)
- Able to read and understand study procedures and participant's information
Key exclusion criteria (8 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-serineCapsule D-serine | Dietary supplement | D-serine group |
| PlaceboCapsule D-serine | Other | Placebo group |
Primary outcome
Total symptom severity
Time frame: 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).
8 secondary outcomes
Subscales symptom severity
Time frame: change from baseline to 6 weeks
Symptom severity and treatment response
Time frame: change from baseline to 6 weeks
Resting-state microstates
Time frame: change from baseline to 6 weeks
Mismatch Negativity (MMN)
Time frame: change from baseline to 6 weeks
Intelligence
Time frame: change from baseline to 6 weeks
Attention and processing speed
Time frame: change from baseline to 6 weeks
Executive functioning
Time frame: change from baseline to 6 weeks
Memory
Time frame: change from baseline to 6 weeks
Results and safety
The study was stopped early (reason given: Poor participant recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-serine in people with Psychotic Disorder, run by Dragos Inta at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor participant recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total symptom severity (time frame: change from baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.