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OpenTrials
Completed

NCT Number: NCT01145313

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pre/post-augmentation healthcare costs and resource utilization among patients diagnosed with MDD who augment antidepressant therapy with an atypical antipsychotic.

    Time frame: 3 months pre- augmentation.

  2. Pre/post-augmentation healthcare costs and resource utilization among patients diagnosed with MDD who augment antidepressant therapy with an atypical antipsychotic.

    Time frame: 3 months post-augmentation.

Secondary outcomes

  1. 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.

    Time frame: 6 month pre-augmentation

  2. 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.

    Time frame: 6 month post-augmentation

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2010
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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