SchizophreniaDSRSZNCT03702933
D-serine in Schizophrenia
An observational study of Schizophrenia, run by Herzog Hospital at 1 site in Israel.
Trial summary
This study will assess the effects of D-serine adjuvant treatment to the ongoing pharmacological treatment of schizophrenia patients that are resistant to treatments. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- D-serine
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2018to 1 Dec 2021
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: schizophrenia patients that do not respond to their treatments
Who may be able to join
- DSM-5 Schizophrenia criteria, able and willing to give informed consent, and comply to study procedure, adequate contraception, post-menopausal or abstinent, PANSS Total Score equal or greater than 70, score of 4 or greater on two psychotic items
Who cannot join
- clinically significant, uncontrollable or unstable medical condition, mental retardation or severe organic brain syndrome, significant risk of suicide or violent behavior
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Herzog Hospital
Jerusalem, 91035
Andrea Durrant, PhD, 972527181489, andy007israel@gmail.com
Uriel Heresco-Levy, MD, 97225316906, urielh@ekmd.huji.ac.il
About this study
Official title: The Effects of Add-On D-serine Pharmacotherapy in Chronic Treatment Resistant Schizophrenia Patients
This study will assess the effects of D-serine adjuvant treatment to the ongoing pharmacological treatment of schizophrenia patients that are resistant to treatments.
- Conditions
- Schizophrenia
- Being tested
- D-serine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-serineDietary supplement
Also called placebo
dosage
| Study group | Role | What they receive |
|---|---|---|
| Placebo | starch Receives: Dietary Supplement: D-serine | |
| High Dose | 3.5 g/d D-serine adjuvant treatment Receives: Dietary Supplement: D-serine | |
| Low Dose | 2.1 g/d D-serine adjuvant treatment Receives: Dietary Supplement: D-serine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS Total Score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Sep 2018
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herzog Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heresco-Levi Uriel, Herzog Hospital
- Investigators
- Uriel Heresco-Levy, MD, Principal investigator, Herzog Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702933
- Sponsor's protocol ID
- HerzogHospital
- Acronym
- DSRSZ
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Add-On D-serine Pharmacotherapy in Chronic Treatment Resistant Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT03702933
- Acronym / sponsor ID
- DSRSZ / HerzogHospital
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Herzog HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 11 Oct 2018 (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.
This study will assess the effects of D-serine adjuvant treatment to the ongoing pharmacological treatment of schizophrenia patients that are resistant to treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | Dietary Supplement: D-serinestarch |
| High Dose | – | Dietary Supplement: D-serine3.5 g/d D-serine adjuvant treatment |
| Low Dose | – | Dietary Supplement: D-serine2.1 g/d D-serine adjuvant treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- schizophrenia patients that do not respond to their treatments
Key inclusion criteria (1 listed)
- DSM-5 Schizophrenia criteria, able and willing to give informed consent, and comply to study procedure, adequate contraception, post-menopausal or abstinent, PANSS Total Score equal or greater than 70, score of 4 or greater on two psychotic items
Key exclusion criteria (1 listed)
- clinically significant, uncontrollable or unstable medical condition, mental retardation or severe organic brain syndrome, significant risk of suicide or violent behavior
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-serineAlso: placebodosage | Dietary supplement | High Dose, Low Dose, Placebo |
Primary outcome
PANSS Total Score
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
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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.
Uriel Heresco-Levy, MD principal investigator
Herzog Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Herzog Hospital at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Oct 2018. 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact andrea durrant, PhD (972527181489, andy007israel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS Total Score (time frame: 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 11 Oct 2018.