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

NCT01284218 | Completed

• 1 other identifier: CN138-609
• Study Type: observational
• Target: 23,514
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• All cause health care costs

  12 months

Secondary Outcomes (6)

• Health care costs: MDD related, mental health related

  12 months

• Health care resource utilization: All cause, MDD related, mental health related

  12 months

• Duration of index therapies

  12 months

• Medication possession ratio to evaluate adherence

  12 months

• Discontinuation of index therapies

  12 months

Study Arms (5)

Aripiprazole cohort

Other atypical cohort

Other antidepressant cohort

Mood stabilizer cohort

Stimulant cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Commercial health plan members

You may qualify if:

• ≥1 fill for an augmentation therapy medication from Table 1 during the identification period of 01 January 2005 - 30 November 2008.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• i3 Innovus: collaborator

Related Links

• BMS Clinical Trials Disclosure
• Investigator Inquiry form
• For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 8, 2013

Record last verified: 2013-11