Effectiveness of Lithium and Valproate in Treating High-Risk Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effectiveness of two different mood stabilizing medications,
      lithium and valproate, in treating people with bipolar disorder and suicidal behavior.
    

Detailed description: 
      Bipolar disorder, also called manic-depressive illness, is a brain disorder that causes
      dramatic changes in a person's mood and energy. Bipolar disorder normally forms in late
      adolescence or early adulthood and requires treatment for the rest of a person's life. People
      with bipolar disorder undergo periods of extreme happiness and extreme sadness, known as
      episodes of mania and depression. Symptoms of mania can include increased energy, euphoric
      moods, mind racing, aggressive behavior, substance abuse, and poor decision making. Symptoms
      of depression can include persistent feelings of anxiety, guilt, or hopelessness; irregular
      sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities;
      excessive irritability and restlessness; and inability to concentrate. Some people with
      bipolar disorder also become suicidal. Suicidal behaviors are more likely to occur at the
      onset of the illness, making it vital to recognize and treat the disorder early on. Current
      treatments include mood stabilizing medications and psychotherapy. This study will evaluate
      the effectiveness of two different mood stabilizing medications, lithium and valproate, in
      treating people with bipolar disorder and suicidal behavior.

      Participants in this double-blind study will be randomly assigned to take one of two
      medications, either lithium or valproate. In the first 2 to 6 months, depending on clinical
      condition, participants may also be required to take the antidepressant paroxetine and/or the
      medication olanzapine. Participants will attend regular visits to a psychiatrist or a
      psychologist at the Neuroscience Clinic. A blood sample will be taken at each visit to
      monitor medication blood levels. Participants will also undergo periodic routine laboratory
      and urine tests to assure their safety.

      If the psychiatrist feels improvement has occurred by the end of the 2- to 6-month period,
      participants will be gradually taken off paroxetine and/or olanzapine over a 2-week period.
      They will then continue taking the assigned lithium or valproate for the remainder of the
      study. If the psychiatrist feels the condition has worsened, participants will be prescribed
      new medications as needed. These medications include other antidepressants (bupropion or
      venlafaxine) or other antimanic or antipsychotic drugs (perphenazine or haloperidol). Once
      these participants have achieved at least 2 weeks of normal moods, they will be gradually
      taken off all other prescribed medications and will remain taking the assigned lithium or
      valproate. Participants who do not achieve at least 2 weeks of normal moods will stop study
      participation but will still be offered clinical treatment. The remaining participants taking
      only lithium or valproate will continue their regular visits with a psychiatrist for the last
      6 months of the study. The entire study will last 12 months.
    

Intervention name(s): Lithium; Valproic acid
Intervention type(s): Drug; Drug
Intervention description(s): Participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine for a portion of the study.; Participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine for a portion of the study.
Other intervention name(s): Sodium valproate or valproic acid (Depakote)
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment