Memantine add-on for Cognitive and Negative Symptoms of Schizophrenia

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The specific aim of this project is to test if memantine add-on therapy will be helpful for patients with first episode schizophrenia who present with or without cognitive impairments and negative symptoms, to examine the efficacy and safety of memantine as an adjuvant agent to their ongoing maintenance therapy with atypical antipsychotics. Our objectives include:

1. Test memantine add-on by 2 different dosages comparing to a placebo-controlled group of clinically stable first episode schizophrenic patients who are under second-generation antipsychotic maintenance therapy. The results will give us information regarding effective dosage and the profile of adverse drug reactions while using on this population.

2. Examine whether the effect of memantine add-on will be affected by any significant baseline clinical variables or predisposed cognitive deficits. That is to say, if memantine will only demonstrate adjunctive effect on those who are cognitively impaired or its effect is independent from baseline cognitive functioning or the severity of baseline psychopathology.

3. Examine the changes in negative symptoms as the secondary outcomes to see if such a cognitive enhancing effect to be concurrent with an improvement in negative symptoms or independent from changes in negative symptoms.

4. Treat the changes in positive symptoms and other clinical outcomes, such as readmission, being employed/going back to school, and psycho-social functioning scores as the tertiary outcomes to examine the effectiveness of memantine add-on.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Memantine

Criteria

Inclusion Criteria:

• Both male and female outpatients

• Age 18-45 years old at the time of screening

• A diagnosis of schizophrenia based on the Structured Clinical Interview for DSM-IV

• Currently receiving treatment mainly by an atypical antipsychotic (risperidone, olanzapine, amisulpride, 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

Exclusion Criteria:

• 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

• Currently under clozapine treatment

• 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.