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:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01145313
First received: June 15, 2010
Last updated: November 7, 2013
Last verified: August 2010
  Purpose

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.


Condition
Depressive Disorder, Major

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 501
Study Start Date: October 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients diagnosed with Major Depressive Disorder
Patients diagnosed with MDD who are treated with antidepressants and subsequently augment with atypical antipsychotic therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145313

Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01145313     History of Changes
Other Study ID Numbers: CN138-582
Study First Received: June 15, 2010
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 22, 2014