- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02233556
Effect of Memantine on ERP in Early Schizophrenia and Healthy Subjects
Effects of Memantine on Event-related Potential in the Comparison of Patients With Early Schizophrenia and Healthy Subjects
Study Overview
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 as possible confounding variables. We would like to make connection and association between neurobiological and neurocognitive markers for further treatment application.
The specific aim of this project is to test if memantine will influence the ERPs change, as in healthy subjects, in patients with early schizophrenia. The specific study population is been known of just have their first episode psychosis subsided, conventionally defined by significantly improved positive symptoms, yet some of them complaining of cognitive decline or presenting with persistent negative symptoms. Previous study showed improvement in mismatch negativity was correlated with general function improvement in schizophrenia. Although a recent study failed to demonstrate positive effects on residual psychopathology of a group of chronic stable schizophrenic patients. In this study we are targeting at a specific population of early schizophrenic patients to examine the efficacy of memantine on neurobiological markers and possible application to general psychopathology. Our objectives include:
- Test memantine effects on the change of ERPs, especially focus on mismatch negativity.
- Compare the ERP difference between healthy subjects and early schizophrenic patients
- Examine whether the effect of memantine will be affected by any significant baseline clinical variables or predisposed cognitive deficits.
First if we could replicate the ERP change in healthy subjects influenced by memantine, and we could further compare the difference between healthy subjects and patient subjects. It may support the hypothesis of NMDA-type glutamate receptor dysregulation theory in schizophrenia. If further association is detected through larger scale study between ERP and clinical symptoms, we could apply memantine in the add-on treatment of schizophrenia. As memantine is already an approved medicine for treatment of moderate to severe Alzheimer disease in many countries worldwide, hopefully we can add a new indication to its original clinical application. Thus it will become the first medicine that can help a condition which has rendered a lot of schizophrenic patients marked impairments in their social and occupational functioning from the early stage of their life. We believe this impact will be even bigger than the original indication of memantine, which is exclusively for patients with dementia. Rather than delaying deterioration of cognitive functioning in patient's late life, an adjuvant therapy for early intervention in schizophrenia aiming at improving cognitive function and hence restoring social and occupational functioning bears greater impact on a patient's life trajectory and lessen the burden of a society. Furthermore, the results from this project will provide critical evidence to support or refute the hypoglutaminergic theory of schizophrenia, which might be an important complement to the hyperdopaminergic theory. With a better understanding of the pathophysiology of schizophrenia not only focusing on dopaminergic system-related positive symptoms but also glutamatergic system-related cognitive and negative symptoms, will provide theoretic base of psychopharmacology in developing agents targeting at different systems to improve the outcome of schizophrenia from the early stage or even the putative pre-psychotic stage of the illness.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ming-Hsien Hsieh, MD, PhD
- Phone Number: 66790 +886-2-23123456
- Email: mingh@ntuh.gov.tw
Study Locations
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-
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
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Contact:
- Ming-Hsien Hsieh, MD, PhD
- Phone Number: 66790 +886-2-23123456
- Email: mingh@ntuh.gov.tw
-
Sub-Investigator:
- Cheng-Chung Liu, MD, PhD
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Sub-Investigator:
- Yi-Ting Lin, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Memantine
This study has only one arm.
i.e.
Single dose of memantine 20mg
|
Taking 20mg(2 capsules) of memantine, followed by Event related potential assessments as below:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in auditory event-related potentials "MMN"before/after intake of a single dose memantine
Time Frame: 4 hours after intake of a single dose memantine
|
Previous studies revealed deficits in cognition via auditory event-related potential, such as Mismatch Negativity.
This study would compare the effect of single dose memantine in MMN.
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4 hours after intake of a single dose memantine
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in auditory event-related potentials "P50" before/after intake of a single dose memantine
Time Frame: 4 hours after intake of a single dose memantine
|
Previous studies revealed deficits in cognition via auditory event-related potential, such as P50.
This study would compare the effect of single dose memantine in P50
|
4 hours after intake of a single dose memantine
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ming-Hsien Hsieh, MD, PhD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- 201308083MINB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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