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

Completed

• Conditions: Depressive Disorder, Major

• Registration Number: NCT01145313
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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 antidepressant therapy with an atypical antipsychotic.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Status Verified: 2010-08
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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