Status:
COMPLETED
Lamotrigine for Symptoms of Geriatric Bipolar Depression
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Bipolar Disorder
Depression, Bipolar
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed v...
Eligibility Criteria
Inclusion
- Age 60 Years or older
- BP Disorder-I or II: Depressive episode (DSM -IV-TR; SCID-I/P)
- HAM-D score \> 18 (GRID-HAM-D 24-item version)
- Availability of an Informant is encouraged but not required for study participation
Exclusion
- Chronic psychotic conditions, ie. schizophrenia, schizoaffective disorder, delusional disorder
- Contraindication to lamotrigine (Physician interview, medical assessment)
- Documented history of intolerance to lamotrigine
- Patients who have previously failed to respond to at least 12 weeks of treatment with lamotrigine
- Active substance dependence (SCID-I/P) or substance-related safety issues or PI concerns
- Mood Disorder Due to a General Medical Condition or Treatment (Physician interview)
- Rapid cycling (Physician interview): As defined in DSM-IV: At least 4 episodes of mood disturbance in the previous 12 months that meet criteria for a Major Depressive, Manic, Mixed or Hypomanic Episode. Episodes are distinguished either by partial or full remission for at least 2 months or by a switch to an episode of opposite polarity
- Dementia (by DSM-IV or brain degenerative diseases; Physician interview);
- Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English)
- Clinically significant sensory impairment (i.e., cannot see well enough to read consent or visually-presented material; cannot hear well enough to cooperate with interview; Physician interview)
- Recent history of cardiovascular, peripheral vascular events or stroke
- High risk for suicide (e.g., active SI or current intent or plan)
- Inpatient status
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00621842
Start Date
January 1 2008
End Date
March 1 2010
Last Update
December 30 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Weill Medical College of Cornell University
White Plains, New York, United States, 10605
2
University Hospitals Case Medical Center/ Case Western Reserve University
Cleveland, Ohio, United States, 44106
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213