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| Sponsor: | University Hospitals of Cleveland |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | University Hospitals of Cleveland |
| ClinicalTrials.gov Identifier: | NCT00621842 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Depression, Bipolar |
Drug: Lamotrigine regular tablet formulation Drug: Lamotrigine novel formulation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Official Title: | Open-label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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 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. |
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Weill Medical College of Cornell University | |
| White Plains, New York, United States, 10605 | |
| United States, Ohio | |
| University Hospitals Case Medical Center/ Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Baylor College of Medicine/Michael E. DeBakey VAMC | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Martha Sajatovic, MD | Case Western Reserve University School of Medicine |
More Information
| Responsible Party: | Case Western Reserve University School of Medicine ( Martha Sajatovic, MD ) |
| Study ID Numbers: | L0971, GSK110720, IND 78,081 |
| Study First Received: | February 12, 2008 |
| Last Updated: | January 26, 2010 |
| ClinicalTrials.gov Identifier: | NCT00621842 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Geriatric Psychiatry Aged lamotrigine |
|
Depression Molecular Mechanisms of Pharmacological Action Bipolar Disorder Calcium Channel Blockers Cardiovascular Agents Depressive Disorder Pharmacologic Actions Behavioral Symptoms |
Membrane Transport Modulators Affective Disorders, Psychotic Mental Disorders Therapeutic Uses Mood Disorders Lamotrigine Central Nervous System Agents Anticonvulsants |