Official Title: “Open-Label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression”

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 standardized diagnostic interview assessment (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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: Lamotrigine regular tablet formulation
  • 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.
• Drug: Lamotrigine novel formulation
  • Participants will have the option of trying a novel formuation 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Assessment of change in depressive symptoms from baseline on the Montgomery Asberg Depression Rating Scale (MADRS)
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Assessment of adverse effects with standardized rating scales and Udvalg fur Kliniske Undersogelser (UKU)
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Change in depressive symptoms from baseline using the Hamilton Depression Rating Scale (GRID-HAM-D)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change in manic symptoms from baseline using the Young Mania Rating Scale (YMRS)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change from baseline in overall clinical diagnosis using the CGI-BP
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change in or appearance of extrapyramidal symptoms from baseline using the SAS, BAS, and AIMS scales.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change in body weight from baseline
  • Time Frame: 12 weeks
    Safety Issue?: No
• Spontaneous reports of adverse effects
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospitals of Cleveland

Overall Clinical Trial Officials and Contacts

Martha Sajatovic, MD Principal Investigator Case Western Reserve University School of Medicine  

Overall Contact: Kristin Cassidy, MA 216-844-2834 kristin.cassidy@uhhospitals.org

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00621842

Study ID Number: L0971

ClinicalTrials.gov Identifier: NCT00621842

Health Authority: United States: Food and Drug Administration