Status:
COMPLETED
Pharmacogenetic-Directed Treatment for Major Depression
Lead Sponsor:
Assurex Health Inc.
Collaborating Sponsors:
Pine Rest Christian Mental Health Services
Conditions:
Depression
Eligibility:
All Genders
18-80 years
Phase:
NA
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 informatio...
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01261364
Start Date
September 1 2009
End Date
September 1 2011
Last Update
December 3 2015
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