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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284218
• Other study ID #: CN138-609
• Status: Completed
• Phase: N/A
• First received: January 25, 2011
• Last updated: November 7, 2013
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2013
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23514
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	i3 Innovus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause health care costs		12 months	No
Secondary	Health care costs: MDD related, mental health related		12 months	No
Secondary	Health care resource utilization: All cause, MDD related, mental health related		12 months	No
Secondary	Duration of index therapies		12 months	No
Secondary	Medication possession ratio to evaluate adherence		12 months	No
Secondary	Discontinuation of index therapies		12 months	No
Secondary	Therapy switches to a non-index antidepressant or non-index augmentation therapy		12 months	No

External Links

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