SchizophreniaPhase 2NCT01251055
GlyT-1 Inhibitor Treatment for Refractory Schizophrenia
A Phase 2 study testing GlyT-1 inhibitor-1 in people with Schizophrenia and Treatment Refractory, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The etiology of schizophrenia remains unclear In recent one decade, hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for schizophrenia treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Treatment Refractory
- What is being tested?
- GlyT-1 inhibitor-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2010to Oct 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fulfill the criteria of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
- Poor response of clozapine treatment: a 12-week treatment of clozapine without satisfactory response: a severity score of Clinical Global Impression Scale(CGI)>=4, a total score of Positive and Negative Syndrome Scale(PANSS)>= 60, and a Scale for the Assessment of Negative Symptoms(SANS)score of >=40. the doses of clozapine remain stable for at least 12 weeks prior to their enrollment in this proposed study,
- Agree to participate in the study and provide informed consent.
Who cannot join
- current substance abuse or history of substance dependence in the past 6 months
- use of depot antipsychotic in the past 6 months
- serious medical or neurological illness
- pregnancy
- inability to follow protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GlyT-1 Inhibitor Treatment for Refractory Schizophrenia and Its Effects on NMDA Modulation
The etiology of schizophrenia remains unclear In recent one decade, hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for schizophrenia treatment.
To date, refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue. However, the effect of NMDA treatment in refractory schizophrenia is still unknown. Therefore, the primary goal of this study is to investigate the efficacy and safety of NMDA adjuvant therapy in refractory schizophrenia, and to identify the predictors for treatment response to NMDA enhancers.
Read the detailed description
The etiology of schizophrenia remains unclear. In recent one decade, hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for schizophrenia treatment. To date, there have been a few pilot studies exploring the efficacy of NMDA enhancers as adjuvant therapy for schizophrenia, for instance, D-serine (an endogenous agonist of the NMDA-glycine site). They were not only well-tolerated but also synergistic in improving positive, negative and cognitive symptoms in those receiving typical and atypical antipsychotics (except clozapine).
Refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue at present. Previous studies revealed that add-on treatment of D-serine or other agonists of NMDA receptor failed to give significant benefits in such patients. The primary goal of this study is to investigate the efficacy and safety of glycine transporter(GlyT)-1 inhibitor adjuvant therapy in refractory schizophrenia, and to identify the predictors for treatment response to NMDA enhancers.
- Conditions
- Schizophrenia, Treatment Refractory
- Being tested
- GlyT-1 inhibitor-1, Placebo
- Keywords
- N-methyl-D-aspartate receptor, glycine transporter, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlyT-1 inhibitor-1Drug
GlyT-1 inhibitor-1(500) 4# BID
PlaceboDrug
starch
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| GlyT-1 inhibitor-1 | Experimental | GlyT-1 inhibitor-1 4000 mg/day Receives: Drug: GlyT-1 inhibitor-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of psychiatric symptoms
The severity of psychiatric symptoms will be assessed by:
- Positive and Negative Syndrome Scale(PANSS)
- Assessment of Negative symptoms(SANS)
- Global assessment of function(GAF)
Measured: baseline
The severity of psychiatric symptoms
The severity of psychiatric symptoms will be assessed by:
- Positive and Negative Syndrome Scale(PANSS)
- Assessment of Negative symptoms(SANS)
- Global assessment of function(GAF)
Measured: 2 weeks after the trial
The severity of psychiatric symptoms
The severity of psychiatric symptoms will be assessed by:
- Positive and Negative Syndrome Scale(PANSS)
- Assessment of Negative symptoms(SANS)
- Global assessment of function(GAF)
Measured: 4 weeks after the trial
The severity of psychiatric symptoms
The severity of psychiatric symptoms will be assessed by:
- Positive and Negative Syndrome Scale(PANSS)
- Assessment of Negative symptoms(SANS)
- Global assessment of function(GAF)
Measured: 6 weeks after the trial (The end of the trial)
Secondary outcomes (6)
Neurocognitive Function
The neurocognitive functions will be assessed by:
- Wisconsin Card Sorting Test (WCST)
- Wechsler Memory Scale- logical memory
Measured: baseline
Neurocognitive function
The neurocognitive functions will be assessed by:
- Wisconsin Card Sorting Test (WCST)
- Wechsler Memory Scale- logical memory
Measured: 6 weeks after the trial (The end of the trial)
The severity of psychiatric symptoms
The severity of psychiatric symptoms will be assessed by:
- Clinical Global Impression(CGI)
- Subscales of PANSS
Measured: baseline
The severity of psychiatric symptoms
The severity of psychiatric symptoms will be assessed by:
- Clinical Global Impression(CGI)
- Subscales of PANSS
Measured: 2 weeks after the trial
The severity of psychiatric symptoms
The severity of psychiatric symptoms will be assessed by:
- Clinical Global Impression(CGI)
- Subscales of PANSS
Measured: 4 weeks after the trial
The severity of psychiatric symptoms
The severity of psychiatric symptoms will be assessed by:
- Clinical Global Impression(CGI)
- Subscales of PANSS
Measured: 6 weeks after the trial (the end of the trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2013
- Study completionOct 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.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsien-Yuan Lane, China Medical University Hospital
- Investigators
- Hsien-Yuan Lane, MD.PhD., Principal investigator, Department of Psychiatry, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251055
- Sponsor's protocol ID
- DMR-98-096
- Status last verified
- Oct 2013
- First submitted
- 3 Nov 2010
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlyT-1 Inhibitor Treatment for Refractory Schizophrenia and Its Effects on NMDA Modulation
- ClinicalTrials.gov ID
- NCT01251055
- Acronym / sponsor ID
- DMR-98-096
- Conditions
- Schizophrenia, Treatment Refractory
- Keywords
- N-methyl-D-aspartate receptor, glycine transporter, schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Dec 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.
The etiology of schizophrenia remains unclear In recent one decade, hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for schizophrenia treatment.
To date, refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue. However, the effect of NMDA treatment in refractory schizophrenia is still unknown. Therefore, the primary goal of this study is to investigate the efficacy and safety of NMDA adjuvant therapy in refractory schizophrenia, and to identify the predictors for treatment response to NMDA enhancers.
Detailed description
The etiology of schizophrenia remains unclear. In recent one decade, hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for schizophrenia treatment. To date, there have been a few pilot studies exploring the efficacy of NMDA enhancers as adjuvant therapy for schizophrenia, for instance, D-serine (an endogenous agonist of the NMDA-glycine site). They were not only well-tolerated but also synergistic in improving positive, negative and cognitive symptoms in those receiving typical and atypical antipsychotics (except clozapine).
Refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue at present. Previous studies revealed that add-on treatment of D-serine or other agonists of NMDA receptor failed to give significant benefits in such patients. The primary goal of this study is to investigate the efficacy and safety of glycine transporter(GlyT)-1 inhibitor adjuvant therapy in refractory schizophrenia, and to identify the predictors for treatment response to NMDA enhancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| GlyT-1 inhibitor-1 | Experimental | Drug: GlyT-1 inhibitor-1GlyT-1 inhibitor-1 4000 mg/day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fulfill the criteria of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
- Poor response of clozapine treatment: a 12-week treatment of clozapine without satisfactory response: a severity score of Clinical Global Impression Scale(CGI)>=4, a total score of Positive and Negative Syndrome Scale(PANSS)>= 60, and a Scale for the Assessment of Negative Symptoms(SANS)score of >=40. the doses of clozapine remain stable for at least 12 weeks prior to their enrollment in this proposed study,
- Agree to participate in the study and provide informed consent.
Key exclusion criteria (5 listed)
- current substance abuse or history of substance dependence in the past 6 months
- use of depot antipsychotic in the past 6 months
- serious medical or neurological illness
- pregnancy
- inability to follow protocol.
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 |
|---|---|---|
| GlyT-1 inhibitor-1GlyT-1 inhibitor-1(500) 4# BID | Drug | GlyT-1 inhibitor-1 |
| Placebostarch | Drug | Placebo |
Primary outcome
The severity of psychiatric symptoms
Time frame: baseline
The severity of psychiatric symptoms will be assessed by: 1. Positive and Negative Syndrome Scale(PANSS) 2. Assessment of Negative symptoms(SANS) 3. Global assessment of function(GAF)
The severity of psychiatric symptoms
Time frame: 2 weeks after the trial
The severity of psychiatric symptoms will be assessed by: 1. Positive and Negative Syndrome Scale(PANSS) 2. Assessment of Negative symptoms(SANS) 3. Global assessment of function(GAF)
The severity of psychiatric symptoms
Time frame: 4 weeks after the trial
The severity of psychiatric symptoms will be assessed by: 1. Positive and Negative Syndrome Scale(PANSS) 2. Assessment of Negative symptoms(SANS) 3. Global assessment of function(GAF)
The severity of psychiatric symptoms
Time frame: 6 weeks after the trial (The end of the trial)
The severity of psychiatric symptoms will be assessed by: 1. Positive and Negative Syndrome Scale(PANSS) 2. Assessment of Negative symptoms(SANS) 3. Global assessment of function(GAF)
6 secondary outcomes
Neurocognitive Function
Time frame: baseline
Neurocognitive function
Time frame: 6 weeks after the trial (The end of the trial)
The severity of psychiatric symptoms
Time frame: baseline
The severity of psychiatric symptoms
Time frame: 2 weeks after the trial
The severity of psychiatric symptoms
Time frame: 4 weeks after the trial
The severity of psychiatric symptoms
Time frame: 6 weeks after the trial (the end of the trial)
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 29 Oct 2013.
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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.
Hsien-Yuan Lane, MD.PhD. principal investigator
Department of Psychiatry, 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 GlyT-1 inhibitor-1 in people with Schizophrenia and Treatment Refractory, run by China Medical University 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 3 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: finished, as of the sponsor's last update on 29 Oct 2013. 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?
The severity of psychiatric symptoms (time frame: baseline). The study lists 4 primary outcomes in all. 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 29 Oct 2013.