Lamotrigine for Symptoms of Geriatric Bipolar Depression
Completed · Phase 3
Conditions studied: Bipolar Disorder, Depression, Bipolar
In brief
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 via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.
Key facts
- Study ID
- NCT00621842
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 57
- Starts
- 2008-01-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2014-12-30
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Weill Medical College of Cornell University — White Plains, New York, United States
- University Hospitals Case Medical Center/ Case Western Reserve University — Cleveland, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States
- Baylor College of Medicine/Michael E. DeBakey VAMC — Houston, Texas, United States
Full record on ClinicalTrials.gov
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