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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01416220 |
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Date of registration:
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11/08/2011 |
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Primary sponsor: |
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Public title:
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Lithium Versus Paroxetine in Major Depression
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Scientific title:
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A Randomized, Open-label, Trial of Lithium Versus Paroxetine in Subjects With Major Depression Who Have a Family History of Bipolar Disorder or Completed Suicide |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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76 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01416220 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Julie Garnham, BN |
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Address:
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Telephone:
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902-473-7144 |
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Email:
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jgarnham@dal.ca |
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Affiliation:
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Name:
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Claire O'Donovan, MD, FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Queen Elizabeth II Health Sciences Centre, CDHA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- men or women
- age of 18 years or older
- meet criteria for major depressive episode, and have a family history of bipolar
disorder or completed suicide
Exclusion Criteria:
- subjects not able to give informed consent
- pregnant or breast-feeding women
- current panic disorder, post traumatic stress disorder or psychosis
- subjects with a history of mania or hypomania
- subjects with active substance abuse or dependence in the last 6 months
- current depressive episode less than 4 weeks or greater than 12 months in duration
- adequate trial of lithium or paroxetine (lithium level = 0.6mmols/l; paroxetine 20mgs
= 5 weeks) for this episode of depression
- concurrent use of other antidepressants or augmenting agents for the treatment of
depression
- clinically significant medical illness, in particular renal impairment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Intervention(s)
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Drug: Lithium
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Drug: Paroxetine
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Primary Outcome(s)
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Montgomery Asberg Depression Rating Scale (MADRS)
[Time Frame: Assessed after 6 weeks of treatment]
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Secondary Outcome(s)
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Barnes Akathisia Rating Scale (BARS)
[Time Frame: Assessed over 6 weeks of treatment]
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The Clinical Global Impression (CGI)
[Time Frame: Assessed after 6 weeks of treatment]
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The Columbia Suicide Classification Scale
[Time Frame: Assessed over 6 weeks of treatment.]
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The Young Mania Rating Scale (YMRS)
[Time Frame: Assessed after 6 weeks of treatment]
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Treatment -emergent symptom checklist and questionnaire
[Time Frame: Assessed over 6 weeks of treatment]
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Secondary ID(s)
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MoodDig-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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