Outcomes in MEasurement-Based Treatment (COMET)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01141387
First received: June 9, 2010
Last updated: April 18, 2011
Last verified: April 2011
| Tracking Information | |||||
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| First Received Date ICMJE | June 9, 2010 | ||||
| Last Updated Date | April 18, 2011 | ||||
| Start Date ICMJE | May 2009 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Patient-reported depression clinical status and patient-reported global depression severity [ Time Frame: Measured at baseline and 6 monthly follow-up interviews ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01141387 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Outcomes in MEasurement-Based Treatment | ||||
| Official Title ICMJE | Clinical Outcomes in MEasurement-Based Treatment (COMET) | ||||
| Brief Summary | The primary objective for this study is to assess the impact of a measurement based treatment program (MBT) on Major Depressive Disorder (MDD) remission rates in patients whose primary care provider (PCP) receives monthly patient-reported depression severity reports compared to patients whose PCP does not receive monthly reports. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Primary care clinic |
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| Condition ICMJE | Depressive Disorder, Major | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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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 | 914 | ||||
| Completion Date | August 2010 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| 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 | NCT01141387 | ||||
| Other Study ID Numbers ICMJE | CN138-534 | ||||
| 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 | April 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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