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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT01189006
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patient aged ≧18 and ≦60 years.
2. A diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria made by a specialist in psychiatry.
3. Acute exacerbation of schizophrenia.
4. A total of PANSS score of at least 60 at screen.
5. History of schizophrenia ≦ 15 years (from onset of prodromal symptoms).
6. Signed informed consent by patient or legal representative
7. Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
Exclusion Criteria:
1. Women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for duration of study.
2. Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
3. Females who are pregnant or nursing.
4. Patient has received dextromethorphan, or other selective cyclo- oxygenase 2 inhibitors, or other anti-inflammatory medication within 1 week prior to first dose of double-blind medication.
5. Axis-I DSM-IV diagnosis other than schizophrenia or schizoaffective disorder.
6. Current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that in the judgement of the investigator, would compromise patient safety or preclude study participation.
7. History of intolerance to risperidone or dextromethorphan or other Cox-2 inhibitors.
8. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by dextromethorphan.
9. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of double-blind medication.
10. Diagnosis of or treatment for oesophageal, gastric, pyloric channel, or duodenal ulceration or related complications (bleeding and/or perforation) within 30 days prior to receiving first dose of double-blind medication.
11. Inclusion in another schizophrenia study or study for another indication with psychotropics within the last 30 days prior to start of study.
12. Increase in total SGOT, SGPT, gamma-GT, BUN and creatinine by more than 3X ULN (upper limit of normal).
13. History of idiopathic or drug-induced agranulocytosis.
14. Alcohol, illegal or other substance-abuse within 6 months prior to study start, as defined by DSM-IV criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01189006
Study Brief:
Protocol Section:
NCT01189006