Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders

Completed · Not applicable

Conditions studied: Depression, Anxiety

In brief

The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) testing on clinical outcomes in a group of subjects exhibiting neuropsychiatric disorders, such as depression and anxiety, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their treatment. This study will also evaluate whether pharmacogenetic (PGx) testing can reduce adverse drug events, hospitalization rates, hospital length of stay, emergency room visits, disability, death or other serious drug side effects.

Key facts

Study ID

NCT02411123

Run by

AltheaDx

People needed

220

Starts

2015-03-01

Expected to finish

2015-12-01

Last updated by the study team

2015-12-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects between the ages of 18 and 80
• Experiencing or showing evidence of a neuropsychiatric disorder (depression, anxiety, attention deficit hyperactivity disorder and psychosis) as determined by a qualified clinician
• Subjects new to the medical provider
• Willing and able to comply with study procedures
• Able to provide written informed consent

You may not qualify if…

• Unwilling or unable to provide written informed consent and to comply with study procedures
• Any subject for whom providing a buccal swab sample would be contraindicated or not possible
• Subject with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5)
• Abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5x normal, or suspected cirrhosis
• History of malabsorption (short gut syndrome)
• Any gastric or small bowel surgery less than 3 months prior to study enrollment
• Subject is being treated with intravenous medication

Where it is running

• Carolina Partners in Mental HealthCare — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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