SchizophreniaPhase 3NCT02001103
Memantine add-on for Cognitive and Negative Symptoms of Schizophrenia
A Phase 3 study testing Memantine in people with Schizophrenia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chen-Chung Liu, MD,PhD, +886-2-23123456 ext. 66130, chchliu@ntu.edu.tw
Yi-Ting Lin, MD PhD
About this study
Official title: Memantine add-on for Improving Cognitive Impairments and Negative Symptoms in Patients With Schizophrenia
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:
- 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.
- 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.
- 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.
- 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.
Read the detailed description
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.
- Conditions
- Schizophrenia
- Being tested
- Memantine, Placebo
- Keywords
- adjuvant therapy, cognitive deficits, first episode schizophrenia, glutamate hypothesis, memantine, negative symptoms
- Medical subject headings
- Schizophrenia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Ebixa
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.
PlaceboDrug
Capsules with starch inside manufactured using the same capsules as used in the other 2 arms.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Memantine |
| Placebo | Placebo comparator | Clinical follow-up/assessment at week 1, 2, 4, 8, and 12 Treatment duration: 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Week 12
Secondary outcomes (2)
Change from baseline in symptom severity during 12 weeks
Mandarin version Positive and Negative Symptom Scale (PANSS) of Schizophrenia
Measured: 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
Measured: Baseline, Week 1, 2, 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen-Chung Liu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001103
- Sponsor's protocol ID
- 201112171MID
- Status last verified
- Jul 2016
- First submitted
- 27 Nov 2013
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memantine add-on for Improving Cognitive Impairments and Negative Symptoms in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02001103
- Acronym / sponsor ID
- 201112171MID
- Conditions
- Schizophrenia
- Keywords
- adjuvant therapy, cognitive deficits, first episode schizophrenia, glutamate hypothesis, memantine, negative symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Memantine 10 mg/day | Active comparator | Drug: Memantine, Drug: PlaceboDosing titration with 5 mg incremental each week Clinical follow-up/assessment at week 1, 2, 4, 8, and 12 Treatment duration: 12 weeks |
| Memantine 20 mg/day | Active comparator | Drug: MemantineDosing titration with 5 mg incremental each week Clinical follow-up/assessment at week 1, 2, 4, 8, and 12 Treatment duration: 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboClinical follow-up/assessment at week 1, 2, 4, 8, and 12 Treatment duration: 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: EbixaPills 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 | Memantine 10 mg/day, Memantine 20 mg/day |
| PlaceboCapsules with starch inside manufactured using the same capsules as used in the other 2 arms. | Drug | Memantine 10 mg/day, Placebo |
Primary outcome
Change from baseline in neurocognitive function
Time frame: Baseline, Week 12
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).
2 secondary outcomes
Change from baseline in symptom severity during 12 weeks
Time frame: Baseline, Week 1, 2, 4, 8, 12
Change from baseline in adverse events during 12 weeks
Time frame: Baseline, Week 1, 2, 4, 8, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen-Chung Liu, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Memantine in people with Schizophrenia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Chung Liu, MD, PhD (886-2-23123456 ext. 66130, chchliu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in neurocognitive function (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.