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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12605000666628 |
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Date of registration:
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19/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of 8 weeks open label aripiprazole as augmentation therapy in Bipolar II disorder
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Scientific title:
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Efficacy of 8 weeks open label aripiprazole as augmentation therapy in Bipolar II disorder |
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Date of first enrolment:
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08/01/2004 |
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Target sample size:
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25 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12605000666628.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Contacts
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Name:
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Professor Chris Pratt
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Address:
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The Melbourne Clinic
130 Church Street
Richmond VIC 3121
Australia |
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Telephone:
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+61 3 04209350 |
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Email:
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chris.pratt@healthscope.com.au |
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Affiliation:
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Name:
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Professor Isaac Schweitzer
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Address:
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The Melbourne Clinic
130 Church Street
Richmond VIC 3121
Australia |
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Telephone:
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+61 3 04209350 |
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Email:
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schweitz@unimelb.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: A DSM-IV diagnosis of Bipolar I disorder, orA diagnosis of Bipolar II (with 2 days hypomania rather than the 4 day minimum as defined by DSM-IV); Mood episodes over the previous 12 months (one hypomania); Regarded as being unstable by their treating clinician to warrant an additional mood stabiliser;Female patients of childbearing potential must use a medically accepted means of contraception;Provide written informed consent;Able to understand and comply with the requirements of the study.
Exclusion criteria: Use of any prohibited medication, including antipsychotic meds other than aripiprazole, within 7 days of Week 4Use of depot antipsychotics during last 8 weeks. ECT within past 3 monthsPregnancy or lactation, or intention to become pregnantUnstable or inadequately treated clinically significant medical illness, as judged by the investigatorCurrent DSM-IV diagnosis of MDD, schizophrenia or schizoaffective disorder or organic mental disorder or substance or alcohol dependence at enrolment. Co-morbid anxiety disorder may be includedJudged to be at significant risk for suicide.
Age minimum:
18 Years
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Neurological - Other neurological disorders
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Bipolar II Disorder;
Bipolar II Disorder
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Intervention(s)
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Addition of trial medication (aripiprazole) to existing treatment for a period of 8 weeks
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Primary Outcome(s)
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Change in Montgomery Asberg Depression Rating Scale [Measured at weeks 2, 4, and 8]
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Change in Young Mania Rating Scale[Measured at weeks 2, 4, and 8]
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Secondary Outcome(s)
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Visual analogue scales (0 - 10) for mania and depression.[Daily Log]
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Clinical Global Impression (CGI).[Measured at weeks 2, 4, and 8.]
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Mood and sleep chart[Daily Log]
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Source(s) of Monetary Support
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Bristol-Myers Squibb Pharmaceuticals
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Ethics review
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Status: Not approved
Approval date:
Contact:
The Melbourne Clinic
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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