A Phase 3 interventional study of Memantine and Placebo in Schizophrenia, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-07-12.
Sponsored by National Taiwan University Hospital · Phase 3, Interventional, and Treatment
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:
Study design:
This is a 12-week double-blind randomized placebo-controlled trial of memantine add-on to concurrent antipsychotic therapy for clinically stable patients with first episode schizophrenia.
Study procedures:
Patients will be recruited from the outpatient clinic of the study hospital. We will hold information campaigns to encourage referrals once the clinical trial procedure is set. Patients will be assessed for eligibility based on the criteria detailed below. Written informed consent will be obtained from eligible subjects or the subjects' parents if they are younger than the age of 18 years. Baseline clinical and neuropsychological assessments will be done at first. Patients will receive a single dose of memantine 5 mg to test if any allergic reactions to those who have never used it before. And then they will be randomized into 3 groups: the first group receives a target dose of memantine 10 mg/day, the second group receives a target dose of memantine 20 mg/day, and the third is a placebo control group. Both the participants and the clinicians are blinded to the agents and dosage they are taking. The dose titrating schedule for medication groups will be 5 mg/day for the first week with an increment of 5 mg per week to reach their designated targeted dose. So the10 mg add-on group will reach their target dose by the beginning of the second week and the 20 mg/day add-on group will reach their target dose by the beginning of the fourth week. Participants will be scheduled to return visit on week 1, 2, 4, 8, and 12 for dispense of medication and clinical assessments. By the end of the 12-week trial, they will receive all clinical and neuropsychological assessments again.
To use the least resources and to make most use of the information, as well as take into account of attrition, we plan to recruit 40 patients for each group with a total of 120 participants.
3,471 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Clinical follow-up/assessment at week 1, 2, 4, 8, and 12 Treatment duration: 12 weeks
Drug: Placebo
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
Capsules with starch inside manufactured using the same capsules as used in the other 2 arms.
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).
Time frame: Baseline, Week 12
Change from baseline in symptom severity during 12 weeks
Mandarin version Positive and Negative Symptom Scale (PANSS) of Schizophrenia
Time frame: Baseline, Week 1, 2, 4, 8, 12
Change from baseline in adverse events during 12 weeks
Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale
Time frame: Baseline, Week 1, 2, 4, 8, 12
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Taiwan University Hospital