Clinical Study Evaluating Effects of Pharmacogenetic-guided vs Standard-of-Care Treatment on Depression and/or Anxiety

Completed · Not applicable

Conditions studied: Depression, Anxiety

In brief

A prospective, multi-center, randomized, subject and outcome evaluator blind , parallel-group study evaluating the effect of pharmacogenetic-guided versus standard of care treatment for subjects diagnosed with depression and/or anxiety disorders.

Key facts

Study ID

NCT02878928

Run by

AltheaDx

People needed

579

Starts

2016-05-01

Expected to finish

2016-12-01

Last updated by the study team

2016-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects 18 years of age or older.
• Subjects diagnosed with depression and/or anxiety as per the DSM-V criteria or standard of care site procedures and meeting at least one of the following:
• Diagnosed with depression and/or anxiety either new to treatment or currently taking medications for less than 6 weeks.
• Inadequately controlled with medications defined as inadequate efficacy after 6 weeks of a psychotropic treatment or have discontinued psychotropic treatment due to adverse events or intolerability.
• 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 patient for whom providing a buccal swab sample would be contraindicated or not possible.
• Subjects diagnosed as not having anxiety or depression.
• Patients at significant risk for suicide and/or in need of immediate hospitalization as judged by the investigator.
• Diagnosis of Bipolar Disorder, as assessed by patient history or M.I.N.I. response.
• Diagnosis of Schizophrenia or Schizoaffective disorder, as assessed by patient history or M.I.N.I. response.
• History or diagnosis of a personality disorder, as assessed by patient history or M.I.N.I. response.
• History of physical traumatic injury (i.e., TBI) resulting in depression.
• Patients new to psychotherapy (provided by licensed and trained mental health professionals) or have not been on a stable psychotherapy regimen for at least 8 weeks.
• Patients receiving other alternative treatments such as Electroconvulsive Therapy (ECT), Transcranial Magnetic Stimulation (TMS), Vagal Nerve Stimulation (VNS), and Deep Brain Stimulation (DBS).
• Patients with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5).
• Patients with abnormal hepatic function within the last 2 years, (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis).
• Patients with a history of malabsorption (short gut syndrome).
• Patients with any gastric or small bowel surgery less than 3 months prior to study enrollment.
• Patients with significant unstable medical condition, neurological disorders (e.g. epilepsy, Parkinson's disease or stroke) or life threatening disease.
• Patients who are currently being treated for anxiety and /or depression incorporating pharmacogenetic information.
• History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 6 months.
• Patients with any significant substance use disorder as assessed by M.I.N.I. response and judged by the investigator.
• Pregnant or lactating women.

Where it is running

• Adnab Research — Rolling Hills, California, United States
• Artemis Clinical Research — San Diego, California, United States
• Adnab Research — Torrance, California, United States
• Collaborative Neuroscience Network — Torrance, California, United States
• Innovative Clinical Research — Lauderhill, Florida, United States
• Innova Clinical Trials — Miami, Florida, United States
• APG Research — Orlando, Florida, United States
• iResearch Atlanta — Decatur, Georgia, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Medpharmics — Metairie, Louisiana, United States
• Meridian Clinical Research — Norfolk, Nebraska, United States
• United Medical Associates — Binghamton, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• Carolina Partners in Mental HealthCare — Raleigh, North Carolina, United States
• Detweiler Family Medicine — Lansdale, Pennsylvania, United States
• Relaro Medical Trials — Dallas, Texas, United States
• Tidewater Clinical Research — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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