Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder
NCT ID: NCT01145313
Last Updated: 2013-11-08
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
501 participants
OBSERVATIONAL
2007-10-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients diagnosed with Major Depressive Disorder
Patients diagnosed with MDD who are treated with antidepressants and subsequently augment with atypical antipsychotic therapy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* aged 18 to 64 years
* diagnosis of major depressive disorder during the study timeframe (ICD 9 codes 296.2, 296.3, 311)
* evidence of at least 6 consecutive claims for traditional antidepressant therapy with a 30 day supply or at least 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
* must be continually enrolled during the study timeframe and have both medical and pharmacy benefits
* evidence of at least 4 consecutive claims for an atypical antipsychotic prescription with a 30 day supply or 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
* evidence of antidepressant therapy for at least 60 consecutive days prior to the initiation of atypical antipsychotic
* After at least a 60 day trial of traditional antidepressant medications, patient augments with an atypical antipsychotic medication for at least 4 months.
Exclusion Criteria
* have any claims for a diagnosis of schizophrenia, schizoaffective or bipolar disorder during the study period
* have Electroconvulsive therapy (ECT) during the study period
* new augmentation with mood stabilizers, L-thyroxine (T4), L-Thyronine (T3), buspirone, stimulant, or others during the post-period (table 1)
* are pregnant during the study period
* patients with Medicare or Medicaid
18 Years
64 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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CN138-582
Identifier Type: -
Identifier Source: org_study_id