SchizophreniaPhase 2NCT01047592
Treatment of N-methyl-D-aspartate (NMDA) Enhancers for Schizophrenia
A Phase 2 study testing sarcosine and sarcosine+ BE in people with Schizophrenia, run by Chang-Hua Hospital at 1 site in Taiwan.
Trial summary
Hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. To date, several reported trials on adjuvant NMDA-enhancing agents, including glycine and sarcosine (a glycine transporter I inhibitor), demonstrated clinical benefits for schizophrenia patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- sarcosine and sarcosine+ BE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Dec 2013
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The participants fulfill the criteria of schizophrenia according to the
- Diagnostic and Statistic Manual, fourth edition (DSM-IV).
- The participants remain stable schizophrenic symptoms and receive stable antipsychotic regimens at last 8 weeks before enrollment.
- The participants agree to participate in the study and provide informed consent.
Who cannot join
- History of alcohol or substance dependence, history of epilepsy, head trauma or CNS diseases, history of major, untreated medical diseases, mental retardation, pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: N-methyl-D-aspartate (NMDA) Enhancers' Benefit to Schizophrenia Treatment
Hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. To date, several reported trials on adjuvant NMDA-enhancing agents, including glycine and sarcosine (a glycine transporter I inhibitor), demonstrated clinical benefits for schizophrenia patients. This project aims to compare the efficacy and safety of sarcosine and combination of sarcosine and BE, as adjunctive therapy for schizophrenia, and to explore the possible synergistic effects of them. Sixty chronic schizophrenic inpatients will be enrolled in the 12-week double-blind, placebo-controlled trial. The participants receive stable antipsychotic regimens concomitant with sarcosine (2 g/d) (N=21), sarcosine(2 g/d) + BE(1 g/d ) (N=21), and placebo(N=21). Measures of clinical efficacy and side-effects were determined every 3 weeks. Measures of cognitive function were determined at the beginning and the end of the study. The efficacies of three groups are compared, and the characteristics of better responders are analyzed.
Read the detailed description
We will measure clinical efficacy every 3 weeks during the treatment. At the beginning and the end of the trial,We will utilize a battery of tests to assess the effect of the treatment on cognitive functions.The side effect assessments are also performed every 3 weeks. Side effect assessments include Simpson-Angus Rating Scale for extrapyramidal side-effects, Abnormal Involuntary Movement Scale (AIMS) for dyskinesia, and Barnes Akathisia Scale. Systemic side effects are reviewed by applying the Udvalg for Kliniske Undersogelser (UKU) Side-effects Rating Scale. DAAO level, routine laboratory tests, including CBC, biochemistry , urine analysis, and EKG, will be checked at baseline and the end of week 12.
To compare the metabolic syndrome parameters among groups, body mass index, hip size, waist size, blood pressure, fasting blood sugar, triglyceride, and total-cholesterol will be checked at baseline and the end of the study.
- Conditions
- Schizophrenia
- Being tested
- sarcosine, sarcosine+ BE, placebo
- Keywords
- Schizophrenia, cognitive function, N-methyl-D-aspartate receptor
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sarcosineDrug
sarcosine, 2 g/d , oral, for 12 weeks
sarcosine+ BEDrug
sarcosine(2 g/d) + BE (1 g/d ), oral, for 12 weeks
placeboDrug
placebo,oral, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| sarcosine | Active comparator | Not described Receives: Drug: sarcosine |
| sarcosine+ BE | Active comparator | Not described Receives: Drug: sarcosine+ BE |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive, negative, cognitive symptoms of schizophrenia, laboratory tests.
Measured: 12 weeks
Secondary outcomes (1)
The subscales of PANSS,MATRICS, and serum DAAO levels.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2013
- Study completionDec 2013
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang-Hua Hospital
- Sponsor type
- Other government
- Collaborators
- China Medical University Hospital
- Responsible party
- Principal investigator, Chun Yuan Lin , MD, Chang-Hua Hospital
- Investigators
- Chun-yuan Lin, MD, Principal investigator, Changhua HospitalHsien-yuan Lane, MD,PHD, Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047592
- Sponsor's protocol ID
- DMR98-IR-014
- Other IDs
- HAC9814
- Status last verified
- Jul 2014
- First submitted
- 12 Jan 2010
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-methyl-D-aspartate (NMDA) Enhancers' Benefit to Schizophrenia Treatment
- ClinicalTrials.gov ID
- NCT01047592
- Acronym / sponsor ID
- DMR98-IR-014
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, cognitive function, N-methyl-D-aspartate receptor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Chang-Hua HospitalOther government
- Collaborators
- China Medical University Hospital
- Study start
- Mar 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Jan 2010 (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.
Hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. To date, several reported trials on adjuvant NMDA-enhancing agents, including glycine and sarcosine (a glycine transporter I inhibitor), demonstrated clinical benefits for schizophrenia patients. This project aims to compare the efficacy and safety of sarcosine and combination of sarcosine and BE, as adjunctive therapy for schizophrenia, and to explore the possible synergistic effects of them. Sixty chronic schizophrenic inpatients will be enrolled in the 12-week double-blind, placebo-controlled trial. The participants receive stable antipsychotic regimens concomitant with sarcosine (2 g/d) (N=21), sarcosine(2 g/d) + BE(1 g/d ) (N=21), and placebo(N=21). Measures of clinical efficacy and side-effects were determined every 3 weeks. Measures of cognitive function were determined at the beginning and the end of the study. The efficacies of three groups are compared, and the characteristics of better responders are analyzed.
Detailed description
We will measure clinical efficacy every 3 weeks during the treatment. At the beginning and the end of the trial,We will utilize a battery of tests to assess the effect of the treatment on cognitive functions.The side effect assessments are also performed every 3 weeks. Side effect assessments include Simpson-Angus Rating Scale for extrapyramidal side-effects, Abnormal Involuntary Movement Scale (AIMS) for dyskinesia, and Barnes Akathisia Scale. Systemic side effects are reviewed by applying the Udvalg for Kliniske Undersogelser (UKU) Side-effects Rating Scale. DAAO level, routine laboratory tests, including CBC, biochemistry , urine analysis, and EKG, will be checked at baseline and the end of week 12.
To compare the metabolic syndrome parameters among groups, body mass index, hip size, waist size, blood pressure, fasting blood sugar, triglyceride, and total-cholesterol will be checked at baseline and the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sarcosine | Active comparator | Drug: sarcosine |
| sarcosine+ BE | Active comparator | Drug: sarcosine+ BE |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The participants fulfill the criteria of schizophrenia according to the
- Diagnostic and Statistic Manual, fourth edition (DSM-IV).
- The participants remain stable schizophrenic symptoms and receive stable antipsychotic regimens at last 8 weeks before enrollment.
- The participants agree to participate in the study and provide informed consent.
Key exclusion criteria (1 listed)
- History of alcohol or substance dependence, history of epilepsy, head trauma or CNS diseases, history of major, untreated medical diseases, mental retardation, pregnancy or lactation
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 |
|---|---|---|
| sarcosinesarcosine, 2 g/d , oral, for 12 weeks | Drug | sarcosine |
| sarcosine+ BEsarcosine(2 g/d) + BE (1 g/d ), oral, for 12 weeks | Drug | sarcosine+ BE |
| placeboplacebo,oral, for 12 weeks | Drug | Placebo |
Primary outcome
Positive, negative, cognitive symptoms of schizophrenia, laboratory tests.
Time frame: 12 weeks
1 secondary outcome
The subscales of PANSS,MATRICS, and serum DAAO levels.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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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.
Chun-yuan Lin, MD principal investigator
Changhua Hospital
Hsien-yuan Lane, MD,PHD study director
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sarcosine and sarcosine+ BE in people with Schizophrenia, run by Chang-Hua Hospital at 1 site in Taiwan.
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 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: finished, as of the sponsor's last update on 8 Jul 2014. 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 Taiwan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive, negative, cognitive symptoms of schizophrenia, laboratory tests. (time frame: 12 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 8 Jul 2014.