Pharmacogenetic-Directed Treatment for Major Depression

NCT ID: NCT01261364

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-09-30

Brief Summary

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

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

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Treatment as Usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

Treatment as usual

Pharmacogenetic guided treatment

Group Type: EXPERIMENTAL

GeneSightRx

Intervention Type: BEHAVIORAL

Multi-genetic pharmacogenomic panel

Interventions

GeneSightRx

Multi-genetic pharmacogenomic panel

Intervention Type: BEHAVIORAL

Treatment as usual

Treatment as usual

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pine Rest Christian Mental Health Services

OTHER

Sponsor Role: collaborator

Assurex Health Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Furmaga, PharmD

Role: PRINCIPAL_INVESTIGATOR

Pine Rest Mental Health Service

Other Identifiers

10002

Identifier Type: -

Identifier Source: org_study_id