Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder

Conditions
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Depressive Disorder, Major

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients diagnosed with Major Depressive Disorder<br>Patients diagnosed with MDD who are treated with antidepressants and subsequently augment with atypical antipsychotic therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre/post-augmentation healthcare costs and resource utilization among patients diagnosed with MDD who augment antidepressant therapy with an atypical antipsychotic. |  | 3 months pre- augmentation. | 
| Pre/post-augmentation healthcare costs and resource utilization among patients diagnosed with MDD who augment antidepressant therapy with an atypical antipsychotic. |  | 3 months post-augmentation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary post-hoc analysis may be conducted to determine differences in outcomes among patients during a longer treatment period, ie 6 month pre- and 6 month post-augmentation. |  | 6 month pre-augmentation | 
| A secondary post-hoc analysis may be conducted to determine differences in outcomes among patients during a longer treatment period, ie 6 month pre- and 6 month post-augmentation. |  | 6 month post-augmentation |