Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)

This study has been completed.
Sponsor:
Collaborator:
i3 Innovus
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01284218
First received: January 25, 2011
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

To examine the differences in health care utilization and costs between MDD patients on adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.


Condition
Depressive Disorder, Major

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • All cause health care costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health care costs: MDD related, mental health related [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Health care resource utilization: All cause, MDD related, mental health related [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Duration of index therapies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Medication possession ratio to evaluate adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Discontinuation of index therapies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Therapy switches to a non-index antidepressant or non-index augmentation therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 23514
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Aripiprazole cohort
Other atypical cohort
Other antidepressant cohort
Mood stabilizer cohort
Stimulant cohort

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Commercial health plan members

Criteria

Inclusion Criteria:

  • ≥1 fill for an augmentation therapy medication from Table 1 during the identification period of 01 January 2005 - 30 November 2008.
  • 12 months of continuous enrollment with medical and pharmacy benefits each before the index date (pre-index period) and after the index date (post-index period).
  • ≥1 medical claim with a primary International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis for MDD (296.2x, 296.3x, 311.xx) during the pre-index period.
  • Age ≥18 years as of the year of the pre-index period.

Exclusion Criteria:

  • No pharmacy claims for atypical antipsychotics, mood stabilizers, anxiolytics, anticonvulsants, or stimulants, during the pre-index period.
  • No medical claims with primary or secondary diagnoses for non-MDD episodic mood disorders or schizophrenia during the pre-index or post-index periods.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01284218

Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
i3 Innovus
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01284218     History of Changes
Other Study ID Numbers: CN138-609
Study First Received: January 25, 2011
Last Updated: November 7, 2013
Health Authority: United States: No Health Authority

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014