Status:
COMPLETED
Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-64 years
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 anti...
Eligibility Criteria
Inclusion
- Patients who meet the following criteria will be included in the study:
- 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
- Patients are excluded if they:
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT01145313
Start Date
October 1 2007
End Date
June 1 2010
Last Update
November 8 2013
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