Schizophrenia Clinical Trial
Official title:
GlyT-1 Inhibitor Treatment for Refractory Schizophrenia and Its Effects on NMDA Modulation
Verified date | October 2013 |
Source | China Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
baseline | No |
Primary | 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) |
2 weeks after the trial | No |
Primary | 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) |
4 weeks after the trial | No |
Primary | 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) |
6 weeks after the trial (The end of the trial) | No |
Secondary | Neurocognitive Function | The neurocognitive functions will be assessed by: Wisconsin Card Sorting Test (WCST) Wechsler Memory Scale- logical memory |
baseline | No |
Secondary | Neurocognitive function | The neurocognitive functions will be assessed by: Wisconsin Card Sorting Test (WCST) Wechsler Memory Scale- logical memory |
6 weeks after the trial (The end of the trial) | No |
Secondary | The severity of psychiatric symptoms | The severity of psychiatric symptoms will be assessed by: Clinical Global Impression(CGI) Subscales of PANSS |
baseline | No |
Secondary | The severity of psychiatric symptoms | The severity of psychiatric symptoms will be assessed by: Clinical Global Impression(CGI) Subscales of PANSS |
2 weeks after the trial | No |
Secondary | The severity of psychiatric symptoms | The severity of psychiatric symptoms will be assessed by: Clinical Global Impression(CGI) Subscales of PANSS |
4 weeks after the trial | No |
Secondary | The severity of psychiatric symptoms | The severity of psychiatric symptoms will be assessed by: Clinical Global Impression(CGI) Subscales of PANSS |
6 weeks after the trial (the end of the trial) | No |
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