Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
i3 Innovus
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01284218
First received: January 25, 2011
Last updated: July 6, 2012
Last verified: July 2012
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Purpose
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 |
|---|
|
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:
MedlinePlus related topics:
Depression
Drug Information available for:
Aripiprazole
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- All cause health care costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Health care costs: MDD related, mental health related [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Health care resource utilization: All cause, MDD related, mental health related [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Duration of index therapies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Medication possession ratio to evaluate adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Discontinuation of index therapies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Therapy switches to a non-index antidepressant or non-index augmentation therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| 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) |
| Groups/Cohorts |
|---|
| Aripiprazole cohort |
| Other atypical cohort |
| Other antidepressant cohort |
| Mood stabilizer cohort |
| Stimulant cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Commercial health plan members
Criteria
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01284218 History of Changes |
| Other Study ID Numbers: | CN138-609 |
| Study First Received: | January 25, 2011 |
| Last Updated: | July 6, 2012 |
| Health Authority: | United States: No Health Authority |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013