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

This study has been completed.
i3 Innovus
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: January 25, 2011
Last updated: November 7, 2013
Last verified: November 2013
To examine the differences in health care utilization and costs between MDD patients on adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.

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 ]

Secondary Outcome Measures:
  • Health care costs: MDD related, mental health related [ Time Frame: 12 months ]
  • Health care resource utilization: All cause, MDD related, mental health related [ Time Frame: 12 months ]
  • Duration of index therapies [ Time Frame: 12 months ]
  • Medication possession ratio to evaluate adherence [ Time Frame: 12 months ]
  • Discontinuation of index therapies [ Time Frame: 12 months ]
  • Therapy switches to a non-index antidepressant or non-index augmentation therapy [ Time Frame: 12 months ]

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)
Aripiprazole cohort
Other atypical cohort
Other antidepressant cohort
Mood stabilizer cohort
Stimulant cohort


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Commercial health plan members

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.
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Please refer to this study by its identifier: NCT01284218

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

Additional Information:
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT01284218     History of Changes
Other Study ID Numbers: CN138-609
Study First Received: January 25, 2011
Last Updated: November 7, 2013

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 25, 2017