Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01145313
First received: June 15, 2010
Last updated: August 5, 2010
Last verified: August 2010
| Tracking Information | |||||
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| First Received Date ICMJE | June 15, 2010 | ||||
| Last Updated Date | August 5, 2010 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01145313 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder | ||||
| Official Title ICMJE | Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder | ||||
| Brief Summary | The primary objective is to examine changes in pre/post-augmentation healthcare costs and resource utilization in patients diagnosed with major depressive disorder (MDD) who augment their current antidepressant therapy with an atypical antipsychotic. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The population is identified as patients diagnosed with MDD who are treated with antidepressants and subsequently augment with atypical antipsychotic therapy. |
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| Condition ICMJE | Depressive Disorder, Major | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Patients diagnosed with Major Depressive Disorder
Patients diagnosed with MDD who are treated with antidepressants and subsequently augment with atypical antipsychotic therapy. |
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| 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 | Completed | ||||
| Enrollment ICMJE | 501 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients who meet the following criteria will be included in the study:
Exclusion Criteria: Patients are excluded if they:
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| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01145313 | ||||
| Other Study ID Numbers ICMJE | CN138-582 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Study Director, Bristol-Myers Squibb | ||||
| Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
| Collaborators ICMJE | Otsuka Pharmaceutical Co., Ltd. | ||||
| Investigators ICMJE |
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| Information Provided By | Bristol-Myers Squibb | ||||
| Verification Date | August 2010 | ||||
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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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