Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm

NCT ID: NCT01632267

Last Updated: 2016-01-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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Antidepressants are among the most widely prescribed medications, yet only 35-45% of patients achieve remission following an initial antidepressant trial. The financial burden of treatment failures in direct treatment costs, disability, decreased productivity, and missed work may in part derive from a mismatch between optimal, and actual, medications prescribed. The present one year retrospective study seeks to evaluate the indirect and direct healthcare costs for 96 patients with a DSM-IV-TR depressive or anxiety disorder, in relation to an interpretive reporting system designed to predict antidepressant responses based on DNA variations in cytochrome P450 genes (CYP2D6, CYP2C19, CYP1A2), the serotonin transporter gene (SLC6A4), and the serotonin 2A receptor (5HTR2A) genes.

Detailed Description

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Conditions

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Depression Anxiety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Depression and anxiety

Subjects with a primary diagnosis of depression or anxiety disorder.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Major Depressive Disorder
* Dysthymic Disorder
* Depressive Disorder NOS
* Obsessive Compulsive Disorder (OCD)
* Generalized Anxiety Disorder
* Panic Disorder
* Anxiety Disorder NOS
* Post-Traumatic Stress Disorder (PTSD)
* Social Phobia

Exclusion Criteria

* Bipolar Disorder
* Schizophrenia
* Schizoaffective Disorder
* Previous pharmacogenomic testing
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assurex Health Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aida Spahic-Mihajlovic, MD

Role: PRINCIPAL_INVESTIGATOR

Union Health Services

Locations

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Union Health Services

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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10003

Identifier Type: -

Identifier Source: org_study_id

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