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OpenTrials
Completed

NCT Number: NCT01284218

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

To examine the differences in health care utilization and costs between MDD patients on adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.

Completed

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. All cause health care costs

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • i3 Innovus

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2011
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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