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GlyT-1 Inhibitor Treatment for Refractory Schizophrenia

NCT ID: NCT01251055

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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

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Schizophrenia Treatment Refractory

Keywords

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N-methyl-D-aspartate receptor glycine transporter schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

starch

GlyT-1 inhibitor-1

GlyT-1 inhibitor-1 4000 mg/day

Group Type EXPERIMENTAL

GlyT-1 inhibitor-1

Intervention Type DRUG

GlyT-1 inhibitor-1(500) 4# BID

Interventions

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GlyT-1 inhibitor-1

GlyT-1 inhibitor-1(500) 4# BID

Intervention Type DRUG

Placebo

starch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hsien-Yuan Lane

Department of Psychiatry, China Medical University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hsien-Yuan Lane, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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DMR-98-096

Identifier Type: -

Identifier Source: org_study_id