Schizophrenia and Schizoaffective DisorderNCT01804920
D-Serine Treatment For Tardive Dyskinesia
A study testing D-serine in people with Schizophrenia and Schizoaffective Disorder and Tardive Dyskinesia, run by Herzog Hospital at 1 site in Israel.
Trial summary
Presently no generally effective treatments for tardive dyskinesia (TD) are available. D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric modulator at the glycine site associated with the glutamatergic NMDA receptor. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia and Schizoaffective Disorder, Tardive Dyskinesia
- What is being tested?
- D-serine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70;
- diagnosis of schizophrenia/schizoaffective disorder according to DSM-IV criteria; diagnosis will be made on the basis of SCID interview and information from medical records, previous treating psychiatrists, and family informants;
- history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks;
- fulfillment of Schooler-Kane TD research criteria on a first evaluation performed 2-12 weeks prior to study entrance and on a subsequent evaluation performed prior to allocation to experimental treatment.
Who cannot join
- meeting criteria for other DSM-IV Axis I diagnoses;
- presence of a neurological disorder or history of significant head injury;
- substance abuse or alcoholism during entire lifetime;
- are judged clinically to be at suicidal or homicidal risk;
- female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D-SERINE TREATMENT FOR TARDIVE DYSKINESIA
Presently no generally effective treatments for tardive dyskinesia (TD) are available. D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous studies have suggested that D-serine may improve motor symptoms, including dyskinesias, which are caused by treatment with presently used antipsychotics drugs.
The hypothesis under investigation in the present study is that D-serine adjuvant treatment may improve TD in schizophrenia patients diagnosed with this disorder.
- Being tested
- D-serine, Placebo
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-serineDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| D-serine adjuvant treatment | Experimental | Random assignment, parallel group, double blind, placebo controlled 8 weeks trial.
First arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment Receives: Dietary Supplement: D-serine |
| Placebo adjuvant treatment | Placebo comparator | Random assignment, parallel group, double blind, placebo controlled 8 weeks trial.
First arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AIMS total score
Measured: biweekly during a period of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Schizoaffective 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
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
- NCT01804920
- Sponsor's protocol ID
- 1600
- Status last verified
- Oct 2018
- First submitted
- 3 Mar 2013
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
- D-SERINE TREATMENT FOR TARDIVE DYSKINESIA
- ClinicalTrials.gov ID
- NCT01804920
- Acronym / sponsor ID
- 1600
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Herzog HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 5 Mar 2013 (estimated)
- 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.
Presently no generally effective treatments for tardive dyskinesia (TD) are available. D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous studies have suggested that D-serine may improve motor symptoms, including dyskinesias, which are caused by treatment with presently used antipsychotics drugs.
The hypothesis under investigation in the present study is that D-serine adjuvant treatment may improve TD in schizophrenia patients diagnosed with this disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-serine adjuvant treatment | Experimental | Dietary Supplement: D-serineRandom assignment, parallel group, double blind, placebo controlled 8 weeks trial. First arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment |
| Placebo adjuvant treatment | Placebo comparator | Dietary Supplement: PlaceboRandom assignment, parallel group, double blind, placebo controlled 8 weeks trial. First arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-70;
- diagnosis of schizophrenia/schizoaffective disorder according to DSM-IV criteria; diagnosis will be made on the basis of SCID interview and information from medical records, previous treating psychiatrists, and family informants;
- history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks;
- fulfillment of Schooler-Kane TD research criteria on a first evaluation performed 2-12 weeks prior to study entrance and on a subsequent evaluation performed prior to allocation to experimental treatment.
Key exclusion criteria (5 listed)
- meeting criteria for other DSM-IV Axis I diagnoses;
- presence of a neurological disorder or history of significant head injury;
- substance abuse or alcoholism during entire lifetime;
- are judged clinically to be at suicidal or homicidal risk;
- female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception.
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-serine | Dietary supplement | D-serine adjuvant treatment |
| Placebo | Dietary supplement | Placebo adjuvant treatment |
Primary outcome
Change in AIMS total score
Time frame: biweekly during a period of 8 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?
A study testing D-serine in people with Schizophrenia and Schizoaffective Disorder and Tardive Dyskinesia, 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 4 inclusion and 5 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. 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?
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?
Change in AIMS total score (time frame: biweekly during a period of 8 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.