Escitalopram as a Mood Stabilizer for Bipolar II Disorder
Condition: Bipolar Disorders
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the efficacy of Escitalopram, a Selective Serotonin Reuptake
      Inhibitor (SSRI) antidepressant, in the treatment of Bipolar II Disorder.

      The use of antidepressants for those with bipolar disorder appears common in clinical
      practice but is not countenanced - at least as monotherapy - in formal treatment guidelines.
      This view reflects concerns about the possibility of antidepressant drugs inducing switching
      and rapid cycling in those with Bipolar Disorder. Although the effectiveness of treating
      Bipolar II patients with SSRIs has received very little attention in the literature,
      observations of Bipolar II patients treated with SSRIs suggest they may have general mood
      stabilising properties. Many patients have reported improvements not only in their depressed
      mood, but also a reduction in the severity, duration and frequency of hypomanic episodes.

      In this proof of concept study we specifically assess whether a standard dose of an SSRI
      antidepressant is more effective than placebo in reducing the frequency, severity and
      duration of both depressive and hypomanic episodes.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, cross-over trial of
      Escitalopram (10 mg) versus placebo (identical presentation) in subjects identified as having
      Bipolar II Disorder. The nine-month study will commence with a no-treatment baseline period
      of three months (Baseline Phase) to ensure that subjects meet criteria for episode frequency.
      Subjects compliant with and completing baseline period requirements will then be randomized
      to receive Escitalopram or placebo for three months (Phase 2) and will then subsequently
      cross over to receive the alternative compound for the final three-month period (Phase 3).
      Prior to that cross-over, there will be a two-day taper period to avoid potential withdrawal
      effects, followed by a seven-day wash-out period to avoid carry-over effects from drug to
      placebo. Subjects will be assessed at the start of the study, and every month thereafter for
      the entire nine-month period.

      Subjects aged 18-65 meeting diagnostic criteria for Bipolar II disorder will be recruited.
      Diagnosis will be based on the Diagnostic and Statistical Manual of Mental Disorders with the
      exception of the minimum four-day duration criterion for hypomanic episodes. Subjects must
      have a minimum 2-year history of depressive and hypomanic episodes, with a mood disturbance
      (either 'high' or 'low') occurring at least monthly. Subjects will be excluded if they have
      previously been treated with anti-depressants or mood-stabilisers, or have a history of
      psychotic symptoms during episodes of either hypomania or depression. Subjects who are
      actively suicidal, have a significant personality disorder, substantive illicit drug use, or
      alcohol consumption >30g/day will also be excluded. Exclusion will also apply to subjects who
      are pregnant or breastfeeding, and those with a history of heart disease, liver disease,
      epilepsy or seizures.

      Subjects will complete a number of self-report questionnaires about their mood and
      functioning on a monthly basis as well as monitoring their mood on a daily basis. A research
      psychologist or psychiatrist will complete (at monthly intervals) the Hamilton Depression
      Rating, Young Mania Rating Scale and the DSM-IV Social and Occupational Functioning
      Assessment Scale based on functioning over the previous week throughout the nine-month
      duration of the study.
    

Intervention name(s): Escitalopram (Lexapro)
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar Disorder; Depression; Hypomania; Mood Stabilizer