Pharmacogenetic-Directed Treatment for Major Depression
|ClinicalTrials.gov Identifier: NCT01261364|
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : December 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: GeneSightRx Behavioral: Treatment as usual||Not Applicable|
|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|
|Actual Primary Completion Date :||January 2011|
|Actual 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261364
|Principal Investigator:||Kevin Furmaga, PharmD||Pine Rest Mental Health Service|