Lamotrigine for Symptoms of Geriatric Bipolar Depression
NCT ID: NCT00621842
Last Updated: 2014-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
57 participants
INTERVENTIONAL
2008-01-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-Label Lamotrigine Treatment
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Martha Sajatovic
Professor of Psychiatry
Principal Investigators
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Martha Sajatovic, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University School of Medicine
Locations
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Weill Medical College of Cornell University
White Plains, New York, United States
University Hospitals Case Medical Center/ Case Western Reserve University
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine/Michael E. DeBakey VAMC
Houston, Texas, United States
Countries
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Other Identifiers
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GSK110720
Identifier Type: -
Identifier Source: secondary_id
IND 78,081
Identifier Type: OTHER
Identifier Source: secondary_id
L0971
Identifier Type: -
Identifier Source: org_study_id