Status:
COMPLETED
Add-on Dextromethorphan in Bipolar Disorders
Lead Sponsor:
National Cheng-Kung University Hospital
Collaborating Sponsors:
National Health Research Institutes, Taiwan
TTY Biopharm
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Dextromethorphan has been reported affording neuroprotection on dopaminergic neurons and having protective effect against inflammation-related neuron damage. These anti-inflammatory and neuroprotectiv...
Eligibility Criteria
Inclusion
- Male or female patient aged ≧18 and ≦65 years.
- A diagnosis of bipolar I or II disorder according to DSM-IV criteria made by a specialist in psychiatry.
- A total of HDRS score at least 18 or YMRS score at least 14 at screen.
- 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 judgment or not willing to comply with contraception for duration of study.
- Females who are pregnant or nursing.
- Patient has received dextromethorphan, or other selective cyclo- oxygenase 2 (Cox-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 bipolar I or II disorder.
- Current evidence of an uncontrolled and/or clinically significant medical condition (e.g., cardiac, hepatic and renal failure), which in the judgments of the investigator, would compromise patient safety or preclude study participation.
- History of intolerance to valproate 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 doubleblind medication.
- Diagnosis of or treatment for esophageal, 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 bipolar disorder study or study for another indication with psychotropic's within the last 30 days prior to start of study.
- Increase in total SGOT, SGPT, BUN and creatinine by more than 3X ULN (upper limit of normal).
- History of idiopathic or drug-induced agranulocytosis.
- Substance-related disorders within 6 months prior to study start, borderline personality disorder, schizophrenia, or other major psychiatric disorders as defined by DSM-IV criteria.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01188265
Start Date
June 1 2007
End Date
June 1 2011
Last Update
September 17 2013
Active Locations (1)
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1
Ru-Band Lu
Tainan, Taiwan, 704