Bipolar Disorders Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Trial of Escitalopram as a Mood Stabilizer for Bipolar II Disorder
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.
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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