Pharmacogenetic-Directed Treatment for Major Depression

The Evaluation of the Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting:A Randomized Double Blind Pilot Study

Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive report improves outcomes when compared with standard treatment without the availability of genetic information.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Treatment as usual; Behavioral: GeneSightRx

Detailed Description

This study is designed to evaluate the clinical impact of pharmacogenetic (PGx)-directed treatment, as guided by interpretive, algorithmic report in the Pine Rest outpatient behavioral health clinics. The PGx algorithm utilized in this study is the foundation of a novel method of interpreting genetic testing results and reports them in a rapidly delivered format that provides enhanced guidance to psychiatrists in their selection of antidepressant medications

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Major Depressive Disorder (296.2, 296.3) or Depressive Disorder NOS (311.0) by a board certified psychiatrist.
• The patient is referred to the study by their treating psychiatrist or nurse practitioner who is approved by the study investigators to make subject referrals to the study.
• The patient is an outpatient and not in imminent need of inpatient hospitalization for medical or psychiatric reasons.
• Patient's baseline 17-Item Hamilton Depression (HAMD17) Rating score is >14.
• Provide a copy of a physical exam report performed within 6 months prior to study enrollment or undergo a physical exam by either their personal physician, a physician who is a subinvestigator on the study, or a study-contracted physician assistant in internal medicine.
• Undergo a medical history that includes a review of major organ systems by either their treating clinician, a subinvestigator physician, or a study-contracted physician assistant in internal medicine.
• The patient has signed the study informed consent form.

Exclusion Criteria:

• Serious medical illness (as ascertained via inclusion criteria 6 and 7, above).
• Diagnosis of a Bipolar Disorder.
• Diagnosis of Schizophrenia or Schizoaffective disorder.
• Evidence from history, baseline urine drug screen, and/or psychiatric interview of active abuse of alcohol and/or other drugs of abuse within 6 months prior to study enrollment. Patients who occasionally use marijuana may still be eligible if it is determined through psychiatric interview that the level of use does not qualify as abuse, dependence, or addiction. Patients testing positive for opioids or benzodiazepines are eligible if there is no evidence of abuse and it is determined that they are taking opioid analgesics or a benzodiazepine that is prescribed by a licensed prescriber for a medical or psychiatric indication.
• History of prior pharmacogenomic testing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as Usual	Behavioral: Treatment as usual; Treatment as usual
Experimental: Pharmacogenetic guided treatment	Behavioral: GeneSightRx; Multi-genetic pharmacogenomic panel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Score reduction	Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment.	8 weeks
Side effect reduction	Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression response or remission	Percentage of subjects who respond (≥50% decrease in HAMD17 and QIDS-CR* rating) or remit (HAMD17< 7 and QIDS-CR rating < 5) with PGx-guided treatment.	8 weeks
Time to response/remission of depressive symptoms.	Time to response/remission of depressive symptoms.	8 weeks
Medication change	Number of subjects who changed their baseline antidepressant medication regimens.	8 weeks
Health care clinical cost	Health care clinical cost (defined by mental health resource utilization).	8 weeks
Report availability	Percent of time that the PGx interpretive report is completed and available to the psychiatrist/nurse practitioner prior to seeing the patient.	8 weeks
Medication Choice	Proportion of time that the psychiatrist/nurse practitioner prescribed a medication that was recommended by the algorithm.	8 weeks
Physician satisfaction	Physician satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).	8 weeks
Patient Satisfaction	Patient satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).	8 weeks

Collaborators and Investigators

• Sponsor: Assurex Health Inc.
• Collaborators: Pine Rest Christian Mental Health Services
• Investigators: Principal Investigator: Kevin Furmaga, PharmD, Pine Rest Mental Health Service

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 15, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 16, 2010

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: GeneSight; Assurex; AssureRx
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 10002