Lamotrigine for Symptoms of Geriatric Bipolar Depression (Geri-BD SAD)

University Hospitals (UH)

Status and phase

Completed

Phase 3

Conditions

Depression, Bipolar

Bipolar Disorder

Treatments

Drug: Lamotrigine novel formulation

Drug: Lamotrigine regular tablet formulation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00621842

GSK110720

IND 78,081 (Other Identifier)

L0971

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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