Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
914 participants
OBSERVATIONAL
2009-05-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients at the intervention sites
The intervention sites will receive the results of the patient-reported depression severity collected during the phone interviews on a monthly basis. The patients in the intervention arm will be interviewed by phone once per month for 6 months.
No interventions assigned to this group
Patients at the usual care sites
The usual care sites will receive the results of the patient-reported depression severity at the end of the study. Patients in the usual care arm will be interviewed at 3 months and 6 months post study enrollment.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of major depressive disorder
* Prescribed a new prescription for an antidepressant medication on the date of study enrollment and currently taking the medication 'New' is defined as no antidepressant use in the previous 120 days
* Primary depression management is performed by the primary care provider
* Capable of self-management (i.e., taking medications and independently responding to follow-up contacts)
* Able to provide informed consent to participate
* Sufficient ability as judged by the physician to read, understand and complete survey instruments written in English and phone interviews spoken in English
Exclusion Criteria
* Diagnosis of current postpartum depression
* Diagnosis of bereavement less than 8 weeks duration
* Currently pregnant
* History of suicide attempts or current suicide plan
* Need for psychiatric hospitalization at enrollment visit
* History of adjunctive treatments including electroconvulsive treatment (ECT), vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS), magnetic seizure therapy (MST), or deep brain stimulation (DBS)
18 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Bristol -Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Related Links
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BMS Clinical Trials Disclosure
Investigator Inquiry form
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Other Identifiers
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CN138-534
Identifier Type: -
Identifier Source: org_study_id