Status:
COMPLETED
Series Studies of Bipolar Disorder-Valproate add-on Memantine
Lead Sponsor:
National Cheng-Kung University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Bipolar Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
All participants should fulfill the following criteria: aged between 18 and 65 years old, and of domestic Han descendants. Participants will be randomly assigned to either the (1) pharmacotherapy (val...
Eligibility Criteria
Inclusion
- Male or female patient aged \>=18 and \<= 65 years.
- A diagnosis of bipolar II disorder according to DSM-IV-TR 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.
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 memantine or other selective cyclo-oxygenase 2 (Cox-2) inhibitors within 1 week prior to first dose of double-blind medication.
- Axis-I DSM-IV-TR diagnosis other than bipolar 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 memantine or other Cox-2 inhibitors.
- History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by memantine
- Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of doubleblind 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).
- 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 :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT01188148
Start Date
August 1 2009
End Date
October 1 2012
Last Update
September 17 2013
Active Locations (1)
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1
Ru-Band Lu
Tainan, Taiwan, 704