Memantine add-on for Cognitive and Negative Symptoms of Schizophrenia

NCT02001103 | Unknown Phase 3

• 1 other identifier: 201112171MID
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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.

Conditions

Schizophrenia

Keywords

adjuvant therapy; cognitive deficits; first episode schizophrenia; glutamate hypothesis; memantine; negative symptoms

Outcome Measures

Primary Outcomes (1)

• Change from baseline in neurocognitive function

  Continuous Performance Test (CPT), Wisconsin Card Sorting Test (WCST), Wechsler Adult Intelligence Scale-Third Edition (WAIS-III), Trail Making Tests, Mandarin version of Verbal Fluency Test and Wechsler Memory Scale-Third Edition (WMS-III).

  Baseline, Week 12

Secondary Outcomes (2)

• Change from baseline in symptom severity during 12 weeks

  Baseline, Week 1, 2, 4, 8, 12

• Change from baseline in adverse events during 12 weeks

  Baseline, Week 1, 2, 4, 8, 12

Study Arms (3)

Memantine 10 mg/day

ACTIVE COMPARATOR

Dosing titration with 5 mg incremental each week Clinical follow-up/assessment at week 1, 2, 4, 8, and 12 Treatment duration: 12 weeks

Drug: Memantine; Drug: Placebo

Memantine 20 mg/day

ACTIVE COMPARATOR

Dosing titration with 5 mg incremental each week Clinical follow-up/assessment at week 1, 2, 4, 8, and 12 Treatment duration: 12 weeks

Drug: Memantine

Placebo

PLACEBO COMPARATOR

Clinical follow-up/assessment at week 1, 2, 4, 8, and 12 Treatment duration: 12 weeks

Drug: Placebo

Interventions

Memantine DRUG

Pills of memantine, including 5 or 10 mg, all prepared in the same capsules as used in the placebo arm. The Memantine 10 mg intervention arm will take 1 capsule of memantine and 1 capsule of placebo going into week 3.

Also known as: Ebixa

Memantine 10 mg/day; Memantine 20 mg/day

Placebo DRUG

Capsules with starch inside manufactured using the same capsules as used in the other 2 arms.

Memantine 10 mg/day; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Interventions

Memantine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chen-Chung Liu, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Chung Liu, MD, PhD

CONTACT

886-2-23123456; chchliu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 4, 2013
• Study Start: January 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2017
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

TW (1)