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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01145313

Enrollment

501

Registered

2010-06-16

Start date

2007-10-31

Completion date

2010-06-30

Last updated

2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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.

Secondary

Measure	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

Outcome results