Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium Carbonate; Optimized Treatment (OPT)
Intervention description: Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.; The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines.
Intervention MeSH terms: Lithium Carbonate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 283.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Lithium; Symptoms; Medication Changes

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 disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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