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

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01284218
• Collaborator: i3 Innovus (Industry)
• Enrollment: 23,514
• Duration (Months): 11

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major

Study Design

• Study Type: Observational
• Actual Enrollment: 23514 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Aripiprazole cohort
Other atypical cohort
Other antidepressant cohort
Mood stabilizer cohort
Stimulant cohort

Outcome Measures

Primary Outcome Measures

1. All cause health care costs [12 months]

Secondary Outcome Measures

1. Health care costs: MDD related, mental health related [12 months]

2. Health care resource utilization: All cause, MDD related, mental health related [12 months]

3. Duration of index therapies [12 months]

4. Medication possession ratio to evaluate adherence [12 months]

5. Discontinuation of index therapies [12 months]

6. Therapy switches to a non-index antidepressant or non-index augmentation therapy [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.
• i3 Innovus

Investigators

• Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT01284218
• Other Study ID Numbers: CN138-609
• First Posted: Jan 26, 2011
• Last Update Posted: Nov 8, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

No Results Posted as of Nov 8, 2013