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

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ClinicalTrials.gov Identifier: NCT01284218
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : November 8, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
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 : January 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Aripiprazole cohort
Other atypical cohort
Other antidepressant cohort
Mood stabilizer cohort
Stimulant cohort


Outcome Measures

Primary Outcome Measures :
  1. All cause health care costs [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Health care costs: MDD related, mental health related [ Time Frame: 12 months ]
  2. Health care resource utilization: All cause, MDD related, mental health related [ Time Frame: 12 months ]
  3. Duration of index therapies [ Time Frame: 12 months ]
  4. Medication possession ratio to evaluate adherence [ Time Frame: 12 months ]
  5. Discontinuation of index therapies [ Time Frame: 12 months ]
  6. Therapy switches to a non-index antidepressant or non-index augmentation therapy [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284218


Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
i3 Innovus
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01284218     History of Changes
Other Study ID Numbers: CN138-609
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs