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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01284218
Enrollment
23514
Registered
2011-01-26
Start date
2011-01-31
Completion date
2011-12-31
Last updated
2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

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.

Interventions

None listed

Sponsors

i3 Innovus
CollaboratorINDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
All cause health care costs12 months

Secondary

MeasureTime frame
Health care resource utilization: All cause, MDD related, mental health related12 months
Duration of index therapies12 months
Health care costs: MDD related, mental health related12 months
Discontinuation of index therapies12 months
Therapy switches to a non-index antidepressant or non-index augmentation therapy12 months
Medication possession ratio to evaluate adherence12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026