Lamotrigine for Symptoms of Geriatric Bipolar Depression
Condition: Bipolar Disorder; Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Lamotrigine regular tablet formulation; Lamotrigine novel formulation
Intervention description: Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.; Participants will have the option of trying a novel formulation of lamotrigine tablets instead of the lamotrigine regular formulation tablets. The dosing will remain the same regardless of which type of lamotrigine tablet is used.
Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Geriatric Psychiatry; Aged; lamotrigine

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.
    

Eligibility 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