Pharmacogenetic-Directed Treatment for Major Depression
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|ClinicalTrials.gov Identifier: NCT01261364|
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : December 3, 2015
|Condition or disease||Intervention/treatment|
|Depression||Behavioral: GeneSightRx Behavioral: Treatment as usual|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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 Start Date :||September 2009|
|Primary Completion Date :||January 2011|
|Study Completion Date :||September 2011|
|Active Comparator: Treatment as Usual||
Behavioral: Treatment as usual
Treatment as usual
|Experimental: Pharmacogenetic guided treatment||
Multi-genetic pharmacogenomic panel
- Depression Score reduction [ Time Frame: 8 weeks ]Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment.
- Side effect reduction [ Time Frame: 8 weeks ]Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment.
- Depression response or remission [ Time Frame: 8 weeks ]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 Frame: 8 weeks ]Time to response/remission of depressive symptoms.
- Medication change [ Time Frame: 8 weeks ]Number of subjects who changed their baseline antidepressant medication regimens.
- Health care clinical cost [ Time Frame: 8 weeks ]Health care clinical cost (defined by mental health resource utilization).
- Report availability [ Time Frame: 8 weeks ]Percent of time that the PGx interpretive report is completed and available to the psychiatrist/nurse practitioner prior to seeing the patient.
- Medication Choice [ Time Frame: 8 weeks ]Proportion of time that the psychiatrist/nurse practitioner prescribed a medication that was recommended by the algorithm.
- Physician satisfaction [ Time Frame: 8 weeks ]Physician satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).
- Patient Satisfaction [ Time Frame: 8 weeks ]Patient satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261364
|Principal Investigator:||Kevin Furmaga, PharmD||Pine Rest Mental Health Service|