Lamotrigine for Symptoms of Geriatric Bipolar Depression

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: GlaxoSmithKline
• Treatments: Anticonvulsants; Lamotrigine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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