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Sponsors and Collaborators: |
University of Aarhus Stanley Medical Research Institute GlaxoSmithKline |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00226135 |
The purpose of this study is to compare lamotrigine with lithium in the long term treatment of bipolar disorder in terms of new episode preventive potentials.
Condition | Intervention | Phase |
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Bipolar Disorder |
Drug: lithium or lamotrigine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Lamotrigine Versus Lithium in Subjects With Bipolar Affective Disorders - a Randomised Study of Prophylactic Effect |
Estimated Enrollment: | 150 |
Study Start Date: | March 2001 |
Study Completion Date: | December 2006 |
Bipolar disorder is a recurrent lifelong illness. Lithium is still the drug of first choice in the prophylactic treatment. However, lithium’s side effects are considerable. Thus the interest in developing alternatives to lithium has increased, and various antiepileptic drugs have been studied. Among these, lamotrigine, which generally is well tolerated, has been evaluated in industry generated trials. However, for various reasons, the generalisability of the results from these studies is limited. Also the follow-up time is limited. This study is a pragmatic effectiveness study, overcoming some of these limitations, and comparing lamotrigine with that of lithium in terms of their potentials for preventing new episodes in patients with bipolar disorder.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Denmark | |
Aarhus University Psychiatric Hospital | |
Risskov, Denmark, 8240 |
Principal Investigator: | Rasmus W Licht, MD, PhD | Aarhus University Psychiatric Hospital, Risskov, Denmark |
Study ID Numbers: | 2612-1400, 98-rc-316 |
Study First Received: | September 23, 2005 |
Last Updated: | April 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00226135 |
Health Authority: | Denmark: National Board of Health |
Bipolar disorder Treatment Long-term |
Lithium Lamotrigine Randomised Clinical Trial |
Calcium, Dietary Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Lamotrigine |
Mood Disorders Lithium Carbonate Psychotic Disorders Lithium |
Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Calcium Channel Blockers Central Nervous System Depressants Enzyme Inhibitors Cardiovascular Agents |
Antipsychotic Agents Antimanic Agents Pharmacologic Actions Membrane Transport Modulators Pathologic Processes Therapeutic Uses Central Nervous System Agents Anticonvulsants Antidepressive Agents |