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

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01145313
First received: June 15, 2010
Last updated: August 5, 2010
Last verified: August 2010

June 15, 2010
August 5, 2010
October 2007
June 2010   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01145313 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
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Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder
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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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

The population is identified as patients diagnosed with MDD who are treated with antidepressants and subsequently augment with atypical antipsychotic therapy.

Depressive Disorder, Major
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Patients diagnosed with Major Depressive Disorder
Patients diagnosed with MDD who are treated with antidepressants and subsequently augment with atypical antipsychotic therapy.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
501
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01145313
CN138-582
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Otsuka Pharmaceutical Co., Ltd.
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP