Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT02233556
Eligibility Criteria:
Inclusion criteria for patient subjects:
1. Both male and female outpatients
2. Age 20-45 years old at the time of screening
3. A diagnosis of schizophrenia based on the Structured Clinical Interview for DSM-IV
4. A duration of illness for less than 5 years since initially diagnosed as schizophrenia
5. Currently receiving treatment mainly by an atypical antipsychotic (risperidone, olanzapine, amisulpiride, aripiprazole, quetiapine, ziprasidone, paliperidone), including long-acting injectable antipsychotic
6. A first generation antipsychotic agent only for a low-dose, as needed use purpose
7. No revised use of benzodiazepines, antidepressants, anticholinergics, or other concomitant medications during past 3 months
Inclusion criteria for healthy subjects:
1. Both male and female
2. Age 20-45 years old at the time of screening
3. No psychiatric diagnosis based on the Structured Clinical Interview for DSM-IV
4. No current use of any pharmaceutical agents in past 2 weeks
Exclusion criteria for all participants:
1. A score of 5 or more on any of the 7 positive symptom items of the PANSS rating at screening
2. Scores of 4 on at least 3 of the 7 positive symptom items of the PANSS rating at screening
3. A major relapse resulting in readmission or doubling the dosage of previous effective antipsychotic treatment during the course of illness
4. A change of current antipsychotic medication in recent 3 months
5. Mental retardation known as IQ below 70 prior to the diagnosis of schizophrenia
6. A history of pervasive mental disorder or bipolar disorder
7. A medical condition with significant cognitive sequelae
8. A history of substance dependence
9. A history of hypersensitivity to memantine or other drugs of the same class, such as amantadine
10. Pregnancy, plan to get pregnant during the study period, or lactating women
11. Abnormal liver function (AST, ALT higher than doubling the upper limits of normal range) or abnormal renal function (blood creatinine \> 1.3 mg/dL)
12. A history of epilepsy
13. A history of myocardial infarction, congestive heart failure, uncontrolled hypertension, stroke, or severe heart block.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT02233556
Study Brief:
Protocol Section:
NCT02233556