Status:
COMPLETED
Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate whether addition of memantine to bipolar depression patients who have had an incomplete response to lamotrigine (Lamictal) which is frequently used to treat...
Detailed Description
Hypothesis/Objectives: H1: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement on the Hamilton Depression Rating Scale (HDRS) and...
Eligibility Criteria
Inclusion
- : 1) age 18 - 65; 2) satisfy DSM-IV-TR criteria for Bipolar Disorder and Major Depressive Episode; 3) Lamotrigine Inadequate-Response: Defined as already treated with at least 100 mg of lamotrigine for at least 4 weeks but 17 item HDRS rating \> 15; 4) give informed consent as approved by local IRB; 5) if on other antidepressants or mood stabilizers on stable dose for the past 4 weeks.
Exclusion
- 1) comorbid psychotic disorder such as schizophrenia or schizoaffective disorder; 2) significant suicidal or homicidal risk; 3) clinically significant medical illness; 4) allergy or intolerance to lamotrigine or memantine; 5) pregnancy, planning to be pregnant or not using adequate contraception; 6) satisfy criteria for substance dependence within 6 months prior to start of the study; and 7) on any medication with significant adverse interaction with either lamotrigine or memantine.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00305578
Start Date
August 1 2005
End Date
December 1 2011
Last Update
July 18 2016
Active Locations (1)
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1
Indiana University Adult Psychiatric Clinic
Indianapolis, Indiana, United States, 46202