ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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]

03283

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bipolar Disorders

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Frequency, Severity and duration of depressive and hypomanic episodes and impairment.

Timepoint [1]

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]

University of New South Wales - Sydney

Recruitment postcode(s) [1]

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/study/NCT00156325

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Gordon Parker

Address

Black Dog Institute/School of Psychiatry, University of New South Wales

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00156325

Trial Review

Registering a new trial?

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