Effect of Memantine on ERP in Early Schizophrenia and Healthy Subjects

NCT02233556 | Unknown DMC

• 1 other identifier: 201308083MINB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 early stage of the disease. Currently medication intervention significantly improves positive symptoms through dopamine receptor modification, leaving alone the negative symptoms and cognitive impairment. Besides dopamine dysregulation, more and more attention had been paid to the association of N-methyl-D-aspartate (NMDA) type glutamate receptor and schizophrenia, focusing on the neurobiological and cognitive biomarkers change. Memantine, an uncompetitive antagonist of NMDA type glutamate receptor approved as cognitive enhancer for Alzheimer's disease, is a potential candidate for preventing cognitive decline of schizophrenia. Previous randomized clinical trials failed to demonstrate its efficacy on chronic schizophrenic patients and it might be related to the chronic and irreversible disease process. There is also study supporting that memantine induces change in mismatch negativity (MMN) in frontal cortex of healthy subjects. This study will compare the MMN change of healthy subjects and the population of early schizophrenia, who has persistent neurobiological, cognitive biomarkers or negative symptoms despite subsided positive symptoms. Both male and female aged 20-45 years old outpatients with a length of illness for less than 5 years since first diagnosed as schizophrenia, currently receiving treatment by atypical antipsychotics in a relatively stable condition will be recruited. Healthy subjects will be recruited comparing their age and sex. We plan to recruit 10 subjects for both patient and healthy subjects with a total of 20 participants. All participants will receive general clinical, cognitive and event-related potential (ERP) evaluation as baseline before taking medication. Twenty mg of memantine will be given 4 hours before ERP retest. The analyses will be performed based on the change of ERP using paired-t sample test. Baseline clinical and cognitive symptoms will be analyzed as possible confounders.

Conditions

Schizophrenia

Keywords

event-related potential; mismatch negativity; NMDA; Glutamate

Outcome Measures

Primary Outcomes (1)

• Changes in auditory event-related potentials "MMN"before/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.

  4 hours after intake of a single dose memantine

Secondary Outcomes (1)

• Changes in auditory event-related potentials "P50" before/after intake of a single dose memantine

  4 hours after intake of a single dose memantine

Study Arms (1)

Memantine

EXPERIMENTAL

This study has only one arm. i.e. Single dose of memantine 20mg

Drug: Memantine

Interventions

Memantine DRUG

Taking 20mg(2 capsules) of memantine, followed by Event related potential assessments as below: 1. Mismatch negativity(MMN) 2. P50

Also known as: Ebixa 10 mg, manufactured by Lunbeck A/S, Denmark

Memantine

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Memantine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ming-Hsien Hsieh, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Hsien Hsieh, MD, PhD

CONTACT

+886-2-23123456; mingh@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: September 8, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

TW (1)