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.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Aged 18-65 - Minimum two year history of depressive and hypomanic episodes - Mood episodes occuring monthly - Meet DSM-IV criteria for Bipolar II Disorder (with exception of minimum 4 day period for hypomanic episodes) Exclusion Criteria: - Previous treatment with any antidepressant, mood stabilizer or neuroleptic medication - History of psychotic symptoms during hypomanic or depressive episodes - Current suicidal behaviours - Current substantive illicit drug use or alcohol consumption - Significant personality disorder - Pregnancy or breastfeeding - History of heart disease, liver disease, epilepsy or seizures |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | University of New South Wales | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
The University of New South Wales |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency, Severity and duration of depressive and hypomanic episodes and impairment. |
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