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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Escitalopram as a Mood Stabilizer for Bipolar II Disorder
Scientific title
A Double-Blind, Placebo-Controlled Trial of Escitalopram as a Mood Stabilizer for Bipolar II Disorder
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Escitalopram (Lexapro)

Treatment: Drugs: Escitalopram (Lexapro)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Frequency, Severity and duration of depressive and hypomanic episodes and impairment.
Timepoint [1] 0 0

Key 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)
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
The University of New South Wales

Ethics approval
Ethics application status

Brief 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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Gordon Parker
Address 0 0
Black Dog Institute/School of Psychiatry, University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications