Status:
COMPLETED
Add-On Therapy to Risperidonein Schizophrenia
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
These results suggest that the DA neuroprotection provided by DM in the inflammation-related neurodegenerative models is not mediated through the NMDA receptor.
Detailed Description
Liu et al. (2003) have reported that DM protected dopamine (DA) neurons against inflammation-mediated degeneration. Zhang et al.'s (2004) novel finding was that 1-10 μM DM protected DA neurons against...
Eligibility Criteria
Inclusion
- Male or female patient aged ≧18 and ≦60 years.
- A diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria made by a specialist in psychiatry.
- Acute exacerbation of schizophrenia.
- A total of PANSS score of at least 60 at screen.
- History of schizophrenia ≦ 15 years (from onset of prodromal symptoms).
- Signed informed consent by patient or legal representative
- Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
Exclusion
- Women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for duration of study.
- Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
- Females who are pregnant or nursing.
- 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.
- Axis-I DSM-IV diagnosis other than schizophrenia or schizoaffective disorder.
- 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.
- History of intolerance to risperidone or dextromethorphan or other Cox-2 inhibitors.
- History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by dextromethorphan.
- Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of double-blind medication.
- 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.
- Inclusion in another schizophrenia study or study for another indication with psychotropics within the last 30 days prior to start of study.
- Increase in total SGOT, SGPT, gamma-GT, BUN and creatinine by more than 3X ULN (upper limit of normal).
- History of idiopathic or drug-induced agranulocytosis.
- Alcohol, illegal or other substance-abuse within 6 months prior to study start, as defined by DSM-IV criteria.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT01189006
Start Date
January 1 2005
End Date
December 1 2008
Last Update
February 28 2013
Active Locations (1)
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1
Ru-Band Lu
Tainan, Taiwan, 704