Escitalopram and Depression in Elderly Alzheimer's Patients
This study has been terminated.
(Dr. Rabheru left VCH last year and the study was cancelled according to his research coordinator.)
Sponsor:
University of British Columbia
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00488670
First received: June 18, 2007
Last updated: June 2, 2011
Last verified: June 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 18, 2007 | ||||
| Last Updated Date | June 2, 2011 | ||||
| Start Date ICMJE | December 2010 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Cornell Scale for Depression in Dementia (CSDD) from baseline. [ Time Frame: Unspecified ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Change in Cornell Scale for Depression in Dementia (CSDD) from baseline. | ||||
| Change History | Complete list of historical versions of study NCT00488670 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Montgomery-Åsberg Depression Rating Scale; Neuropsychiatric Inventory; Alzheimer's Disease Cooperative Study [ Time Frame: Unspecified ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Montgomery-Åsberg Depression Rating Scale; Neuropsychiatric Inventory; Alzheimer’s Disease Cooperative Study | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Escitalopram and Depression in Elderly Alzheimer's Patients | ||||
| Official Title ICMJE | An Open-label Study of Escitalopram in the Treatment of Major Depressive Disorder in Elderly Patients With Alzheimer's Disease | ||||
| Brief Summary | To investigate the effect of Escitalopram in a large and diverse of dementia patients suffering from depression. |
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| Detailed Description | This study will assess the efficacy, tolerability, and safety of escitalopram in the treatment of Major Depressive Disorder in patients with Alzheimer's disease over a 24-week period. It will also assess the efficacy and tolerability of escitalopram after 12 weeks of treatment. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Depressive Disorder | ||||
| Intervention ICMJE | Drug: Escitalopram
See Detailed Description. |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00488670 | ||||
| Other Study ID Numbers ICMJE | H07-00050 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Kiran Rabheru, University of British Columbia | ||||
| Study Sponsor ICMJE | University of British Columbia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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