Status:
COMPLETED
Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This study evaluated whether lithium included as part of optimized medication treatment improved overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar ...
Detailed Description
Bipolar illness, a brain disorder that causes dramatic changes in a person's mood and energy, affects about 2.6% of adults in the United States. Bipolar disorder is characterized by cyclical periods o...
Eligibility Criteria
Inclusion
- Meets DSM-IV Criteria for bipolar disorder (type I or II)
- Currently symptomatic, as defined as a Clinical Global Impressions Scale-Bipolar Version, Overall Severity Index (CGI-BP-S) of greater than or equal to 3
- If taking or has taken lithium, must be off lithium for at least 30 days before study entry
- If a woman of child bearing potential, agrees to inform their doctor at the earliest possible time of their plans to conceive, to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, total abstinence from intercourse), and to acknowledge the risks of lithium to the fetus and infant (Depo Provera is acceptable if it is started 3 months before study entry)
Exclusion
- Renal impairment (serum creatinine greater than 1.5 mg/dL)
- Thyroid stimulating hormone (TSH) over 20% above the upper normal limit (participants maintained on thyroid medication must be euthyroid for at least 3 months before Visit 1)
- History of lithium toxicity that was not caused by mismanagement or overdose
- Other contraindication to lithium (e.g., hypersensitivity to lithium or any component of the formulation, severe cardiovascular or renal disease, severe debilitation, dehydration, sodium depletion, pregnancy)
- Currently in crisis such that inpatient hospitalization or other crisis - Participated in a clinical trial of an investigational drug within the 1 months before study entry
- Pregnant or breastfeeding
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT00667745
Start Date
April 1 2008
End Date
March 1 2010
Last Update
February 13 2018
Active Locations (6)
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1
Stanford University
Stanford, California, United States, 94035-5723
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Case Western Reserve University
Cleveland, Ohio, United States, 44106
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104