Add-on Dextromethorphan in Bipolar Disorders

Inclusion criteria

• 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 criteria

• 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.