Back to resultsPharmacogenetic-Directed Treatment for Major Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GeneSightRx
Treatment as usual
Sponsored by
About this trial
This is an interventional diagnostic trial for Depression focused on measuring GeneSight, Assurex, AssureRx
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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment as Usual
Pharmacogenetic guided treatment
Arm Description
Outcomes
Primary Outcome Measures
Depression Score reduction
Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment.
Side effect reduction
Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment.
Secondary Outcome Measures
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.
Time to response/remission of depressive symptoms.
Time to response/remission of depressive symptoms.
Medication change
Number of subjects who changed their baseline antidepressant medication regimens.
Health care clinical cost
Health care clinical cost (defined by mental health resource utilization).
Report availability
Percent of time that the PGx interpretive report is completed and available to the psychiatrist/nurse practitioner prior to seeing the patient.
Medication Choice
Proportion of time that the psychiatrist/nurse practitioner prescribed a medication that was recommended by the algorithm.
Physician satisfaction
Physician satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).
Patient Satisfaction
Patient satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).
Full Information
NCT ID
NCT01261364
First Posted
December 15, 2010
Last Updated
December 2, 2015
Sponsor
Assurex Health Inc.
Collaborators
Pine Rest Christian Mental Health Services
1. Study Identification
Unique Protocol Identification Number
NCT01261364
Brief Title
Pharmacogenetic-Directed Treatment for Major Depression
Official Title
The Evaluation of the Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting:A Randomized Double Blind Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assurex Health Inc.
Collaborators
Pine Rest Christian Mental Health Services
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
GeneSight, Assurex, AssureRx
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Title
Pharmacogenetic guided treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
GeneSightRx
Intervention Description
Multi-genetic pharmacogenomic panel
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual
Primary Outcome Measure Information:
Title
Depression Score reduction
Description
Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment.
Time Frame
8 weeks
Title
Side effect reduction
Description
Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Depression response or remission
Description
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.
Time Frame
8 weeks
Title
Time to response/remission of depressive symptoms.
Description
Time to response/remission of depressive symptoms.
Time Frame
8 weeks
Title
Medication change
Description
Number of subjects who changed their baseline antidepressant medication regimens.
Time Frame
8 weeks
Title
Health care clinical cost
Description
Health care clinical cost (defined by mental health resource utilization).
Time Frame
8 weeks
Title
Report availability
Description
Percent of time that the PGx interpretive report is completed and available to the psychiatrist/nurse practitioner prior to seeing the patient.
Time Frame
8 weeks
Title
Medication Choice
Description
Proportion of time that the psychiatrist/nurse practitioner prescribed a medication that was recommended by the algorithm.
Time Frame
8 weeks
Title
Physician satisfaction
Description
Physician satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).
Time Frame
8 weeks
Title
Patient Satisfaction
Description
Patient satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Furmaga, PharmD
Organizational Affiliation
Pine Rest Mental Health Service
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Pharmacogenetic-Directed Treatment for Major Depression
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