GeneSightRx
BehavioralMulti-genetic pharmacogenomic panel
NCT Number: NCT01261364
Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive report improves outcomes when compared with standard treatment without the availability of genetic information.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multi-genetic pharmacogenomic panel
Treatment as usual
Time frame: 8 weeks
Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment.
Time frame: 8 weeks
Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment.
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 frame: 8 weeks
Time to response/remission of depressive symptoms.
Time frame: 8 weeks
Number of subjects who changed their baseline antidepressant medication regimens.
Time frame: 8 weeks
Health care clinical cost (defined by mental health resource utilization).
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.
Time frame: 8 weeks
Proportion of time that the psychiatrist/nurse practitioner prescribed a medication that was recommended by the algorithm.
Time frame: 8 weeks
Physician satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).
Time frame: 8 weeks
Patient satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).
Assurex Health Inc.
Industry
The Evaluation of the Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting:A Randomized Double Blind Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06139016
Behavior, Behavioral Symptoms
New Haven, Connecticut, United States
View Trial DetailsNCT06942637
Adolescents, Anxiety
Bandung, West Java, Indonesia
View Trial DetailsNCT04276259
Behavior, Behavioral Symptoms
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT07737652
Anxiety, Anxiety Disorders
Tuscaloosa, Alabama, United States
View Trial Details