Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2017-04-01

Brief Summary

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This is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS).

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Detailed Description

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Mental illness affects one in four adults in the United States; approximately 61.5 million Americans experience mental illness in a given year. According to the National Alliance for the Mentally Ill, the impact of serious mental illness costs Americans $193.2 billion in lost earnings per year. In addition, mental illness patients have an increased risk of having chronic medical conditions, leading to increased costs and emergency service utilization for those conditions. In addition to substantial costs, patients with psychiatric illness are difficult to treat. More than two-thirds of patients with depression do not respond to first line therapy. Treatment often involves numerous trials of individual agents and combinations of medications in order to achieve optimal response. Pharmacogenetic testing is being used in more settings to guide treatment decisions.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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4-Week Group

Pharmacogenetic testing released to physician at 4 weeks following enrollment into study

Group Type OTHER

pharmacogenetic testing

Intervention Type OTHER

pharmacogenetic testing for anti-depressant/anti-psychotic medications

12-Week Group

Pharmacogenetic testing released to physician at 12 weeks following enrollment into study

Group Type OTHER

pharmacogenetic testing

Intervention Type OTHER

pharmacogenetic testing for anti-depressant/anti-psychotic medications

Interventions

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pharmacogenetic testing

pharmacogenetic testing for anti-depressant/anti-psychotic medications

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Current primary or secondary diagnosis of Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
* Have moderate to severe depression as identified by PHQ-9 scoring of 10 or greater
* Taking or be newly prescribed an anti-depressant or anti-psychotic medication
* Able to provide informed consent

Exclusion Criteria

* Pregnant or breastfeeding
* Active and/or unstable diagnosis of substance abuse, excluding nicotine
* Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schioaffective disorder, or personality disorder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No