Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

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.
    

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 of extreme highs and lows, known as episodes of mania and depression. A
      person undergoing an episode of mania often experiences euphoric moods, increased energy, and
      aggressive behaviors, while a person in a depressed state often experiences low moods, lack
      of energy, and feelings of sadness. Lithium is a widely used mood stabilizing medication that
      has been shown to reduce the occurrence and intensity of manic episodes and may lessen
      depressive episodes as well. Including lithium as a part of a personalized medication
      treatment approach may be the most effective means of improving symptoms of bipolar disorder.
      This study will evaluate whether lithium included as part of optimized medication treatment
      improves overall level of illness, symptoms of mania and depression, and quality of life in
      people with bipolar disorder.

      Participation in this study lasted for 6 months. All participants had an initial assessment
      that included an interview and questionnaires to confirm a diagnosis of bipolar disorder,
      vital sign measurements, a blood draw, and if female, pregnancy. Eligible participants were
      then assigned randomly to receive either optimized medication plus lithium or optimized
      medication without lithium. Participants in both groups received 6 months of monitored
      treatment with their medication regimens, as prescribed by their study doctor. Participants
      attended study visits every 2 weeks for the first 8 weeks and then once a month for 4 more
      months. These visits lasted between 45 and 60 minutes and included medication adjustments and
      questions about symptoms, side effects, and quality of life.

      We would like to acknowledge that medication was kindly donated by Ortho-McNeil Janssen
      Scientific Affairs, LLC.
    

Intervention name(s): Lithium Carbonate; Optimized Treatment (OPT)
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Lithium
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lithium; Symptoms; Medication Changes