Series Studies of Bipolar Disorder-Valproate add-on Memantine

Exclusion Criteria

• •1. Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
• •2. Females who are pregnant or nursing.
• •3. Patient has received memantine or other selective cyclo-oxygenase 2 (Cox-2) inhibitors within 1 week prior to first dose of double-blind medication.
• •4. Axis-I DSM-IV-TR diagnosis other than bipolar II disorder.
• •5. 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.
• •6. History of intolerance to valproate or memantine or other Cox-2 inhibitors.
• •7. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by memantine
• •8. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of doubleblind medication.
• •9. Inclusion in another bipolar disorder study or study for another indication with psychotropic's within the last 30 days prior to start of study.
• •10. Increase in total SGOT, SGPT, BUN and creatinine by more than 3X ULN (upper limit of normal).
• •11. 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.