A Double Blind Pilot Trial to Evaluate Efficacy Trends and Safety of Risperidone and Olanzapine as add-on Therapy to Serotonin Type Antidepressants in Subjects With Treatment Resistant Depression (TRD)
Sponsor study identifier
interventional
42
1 country
1
Study Start
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2004
Actual (reported)Study Completion
March 2004
Actual (reported)Atypical neuroleptics may have antidepressant qualities in bipolar depression and in unipolar depression. Some data support the use of both Risperidone and Olanzapine, but there are no direct comparisons of their relative efficacy and tolerability in treatment resistant depression. The current study was designed as a pilot study to examine efficacy and tolerability of Olanzapine vs. Risperidone add on to a failed serotonin re-uptake inhibitor (SSRI) in depression.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2004
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
March 2004
Actual (reported)March 2004
Actual (reported)January 21, 2011
Actual (reported)January 25, 2011
Actual (reported)Change from Baseline in Hamilton Depression Rating Scale at 1 week
Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6.
day one
Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 1 week
MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6.
day one
Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 1 week
Impact on anxiety will be measured by the HAM-A over the 6 weeks.
day one
Change from Baseline in Hamilton Depression Rating Scale at 2 weeks
Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6.
Clinical Global Improvement Scale - Improvement
day one
Change from Baseline of Weight at 6 weeks
day 43
Commence at 0.5 mg once daily Increase, blindly, to 1 mg and then by 1 mg at discretion of clinicians through weeks 1-4 to a maximum of 3 mg.
Commence at 2.5 mg once daily Increase to 5.0 mg, blindly, and then by 5 mg at the discretion of the clinician through weeks 1 - 4 to a maximum of 15 mg
Risperidone will commence at 0.5 mg per day in a single daily dose given once in the evening. Clinicians will have the option, at each visit of increasing the risperidone dose to a maximum of 3 mg/day based on subject response and tolerability (please see Titration Recommendations below).
Olanzapine will commence at 2.5 mg per day in a single daily dose given once in the evening. Clinicians will have the option, at each visit, of increasing the olanzapine dose to a maximum of 15 mg/day based on subject response and tolerability.
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Anthony Levitt, MD
Sunnybrook Health Sciences Centre
Raymond Lam, MD
University of British Columbia
Yves Chaput, MD
University of Manitoba
Murray Enns, MD
University of McGill
42 participants (actual enrollment reported by the registry).
First Submitted
January 21, 2011
First Posted
January 25, 2011
Study Start
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder
day 8
Change from Baseline in Hamilton Depression Rating Scale at 3 weeks
Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6.
day 15
Change from Baseline in Hamilton Depression Rating Scale at 4 weeks
Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6.
day 22
Change from Baseline in Hamilton Depression Rating Scale at 5 weeks
Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6.
day 29
Change from Baseline in Hamilton Depression Rating Scale at 6 weeks
Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6.
day 43
Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 2 weeks
MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6.
day 8
Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 3 weeks
MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6.
day 15
Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 4 weeks
MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6.
day 22
Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 5 weeks
MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6.
day 29
Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 6 weeks
MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6.
day 43
Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 2 weeks
Impact on anxiety will be measured by the HAM-A over the 6 weeks.
day 8
Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 3 weeks
Impact on anxiety will be measured by the HAM-A over the 6 weeks.
day 15
Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 4 weeks
Impact on anxiety will be measured by the HAM-A over the 6 weeks.
day 15
Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 5 weeks
Impact on anxiety will be measured by the HAM-A over the 6 weeks.
day 22
Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 6 weeks
Impact on anxiety will be measured by the HAM-A over the 6 weeks.
day 43
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Contact the study team to confirm eligibility.
Primary Completion
March 2004
Actual (reported)Study Completion
March 2004
Actual (reported)Last Updated
January 25, 2011
Record last verified: 2010-09
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Source: ClinicalTrials.gov.
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