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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00156325




Registration number
NCT00156325
Ethics application status
Date submitted
8/09/2005
Date registered
12/09/2005
Date last updated
2/01/2006

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
03283
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
Depression

Intervention/exposure
Study type
Interventional
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

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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Treatment
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
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00156325
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00156325