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Sponsored by: |
Mclean Hospital |
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Information provided by: | Mclean Hospital |
ClinicalTrials.gov Identifier: | NCT00720473 |
We propose to study the efficacy and tolerability of lamotrigine in the treatment of older adults with bipolar depression and to compare measures of brain energy metabolism between older subjects with bipolar depression and healthy age-matched controls in order to better understand treatment response in geriatric bipolar depression.
Condition | Intervention |
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Bipolar Depression |
Drug: Lamotrigine |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Lamotrigine Therapy in the Treatment of Geriatric Bipolar Depression: An Evaluation of Markers of Cerebral Energy Metabolism |
Estimated Enrollment: | 35 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Other
Open Label Study
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Drug: Lamotrigine
Lamotrigine with dosage range from 25 mg to 200 mg per day.
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We will use MRI techniques and neuropsychological testing to investigate potential markers of treatment response in elderly bipolar depressed patients receiving lamotrigine and age-matched, non-depressed controls.
We intend to test these hypotheses:
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria (for Bipolar Subjects):
Exclusion Criteria (for Bipolar Subjects):
Inclusion Criteria (for Controls):
Exclusion Criteria (for Controls):
- Same criteria for the Bipolar Depressed group with the exception of the "first episode of mania" which is not applicable.
Contact: Susan Kim, BA | 617-855-2499 | skim@mclean.harvard.edu |
Contact: Brittany Jordan, BA | 617-855-2499 | bjordan@mclean.harvard.edu |
United States, Massachusetts | |
McLean Hospital | Recruiting |
Belmont, Massachusetts, United States, 02478 | |
Contact: Brent Forester, MD 617-855-3622 bforester@mclean.harvard.edu | |
Principal Investigator: Brent P Forester, MD |
Principal Investigator: | Brent P Forester, MD | Mclean Hospital |
Responsible Party: | McLean Hospital ( Brent P. Forester MD ) |
Study ID Numbers: | 2005-P-002493 |
Study First Received: | July 18, 2008 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00720473 |
Health Authority: | United States: Food and Drug Administration |
Bipolar depression Elderly Lamotrigine Brain energy metabolism |
Calcium, Dietary Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder |
Lamotrigine Mood Disorders Psychotic Disorders Depressive Disorder Behavioral Symptoms |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Calcium Channel Blockers |
Cardiovascular Agents Central Nervous System Agents Anticonvulsants Pharmacologic Actions |