Status:
UNKNOWN
Effect of Memantine on ERP in Early Schizophrenia and Healthy Subjects
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Schizophrenia
Eligibility:
All Genders
20-45 years
Phase:
NA
Brief Summary
Patients with schizophrenia are deeply affected by the positive symptoms, negative symptoms and cognitive impairment. A generalized cognitive deficit could be frequently observed and traced back to ea...
Detailed Description
In this proposal, we use one-dose memantine trial to compare the difference of MMN change between healthy subjects and early schizophrenia patients. The cognitive and negative symptoms will be counted...
Eligibility Criteria
Inclusion
- Inclusion criteria for patient subjects:
- Both male and female outpatients
- Age 20-45 years old at the time of screening
- A diagnosis of schizophrenia based on the Structured Clinical Interview for DSM-IV
- A duration of illness for less than 5 years since initially diagnosed as schizophrenia
- Currently receiving treatment mainly by an atypical antipsychotic (risperidone, olanzapine, amisulpiride, aripiprazole, quetiapine, ziprasidone, paliperidone), including long-acting injectable antipsychotic
- A first generation antipsychotic agent only for a low-dose, as needed use purpose
- No revised use of benzodiazepines, antidepressants, anticholinergics, or other concomitant medications during past 3 months
- Inclusion criteria for healthy subjects:
- Both male and female
- Age 20-45 years old at the time of screening
- No psychiatric diagnosis based on the Structured Clinical Interview for DSM-IV
- No current use of any pharmaceutical agents in past 2 weeks
- Exclusion criteria for all participants:
- A score of 5 or more on any of the 7 positive symptom items of the PANSS rating at screening
- Scores of 4 on at least 3 of the 7 positive symptom items of the PANSS rating at screening
- A major relapse resulting in readmission or doubling the dosage of previous effective antipsychotic treatment during the course of illness
- A change of current antipsychotic medication in recent 3 months
- Mental retardation known as IQ below 70 prior to the diagnosis of schizophrenia
- A history of pervasive mental disorder or bipolar disorder
- A medical condition with significant cognitive sequelae
- A history of substance dependence
- A history of hypersensitivity to memantine or other drugs of the same class, such as amantadine
- Pregnancy, plan to get pregnant during the study period, or lactating women
- Abnormal liver function (AST, ALT higher than doubling the upper limits of normal range) or abnormal renal function (blood creatinine \> 1.3 mg/dL)
- A history of epilepsy
- A history of myocardial infarction, congestive heart failure, uncontrolled hypertension, stroke, or severe heart block.
Exclusion
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02233556
Start Date
February 1 2014
End Date
December 1 2016
Last Update
December 14 2015
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, Taiwan, 100