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Memantine add-on for Cognitive and Negative Symptoms of Schizophrenia

NCT02001103 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-07-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Memantine

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chen-Chung Liu, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-07-31
Completion
2017-12-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02001103 on ClinicalTrials.gov