N/A
N=227
Evaluation of an Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting
Depression
Bottom Line
View on ClinicalTrials.gov: NCT01610063 ↗Enrolled (actual)
227
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline — -41.2; -11.0; -48.4; -31.8 Percentage change in depression rating — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacogenomic algorithm (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline |
-41.2; -11.0; -48.4; -31.8 | <0.0001 sig |
| SECONDARY Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline |
-42.2; -15.0; -49.5; -35.6 | <0.0001 sig |
| SECONDARY Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline |
-46.3; -15.5; -44.0; -20.7 | 0.002 sig |
| SECONDARY Percentage Change in Outcome by Bin Status and Treatment Group |
-42.2; -15.0; -49.5; -35.6; -41.2; -11 | — |
| SECONDARY Pharmacogenomic Report Utilization |
76.8; 44.1; 93.8; 55.6 | — |
| SECONDARY Physicians' Perception of Participant's Satisfaction With Their Care |
40.5; 14.8; 94.6; 61.8; 91.9; 61.8 | — |
| SECONDARY Responders at Week 8 |
43.1; 26.9; 50.7; 31.2; 44.4; 23.7 | — |
| SECONDARY Remitters at Week 8 |
30.6; 21.5; 25.4; 16.1; 26.4; 12.9 | — |
Summary
This was a study of a genotyping tool that reported on how subjects responded to medications and could be used in a community psychiatry practice to improve medication choice for depression. After the DNA test, an interpretive report was provided to the subjects' physicians. The hypothesis of this pilot study was that it was feasible to use this pharmacogenomic algorithm in a new setting to treat depressed subjects..
Eligibility Criteria
Inclusion Criteria
- Patient is between the ages of 18 and 80.
- Major depressive disorder or depressive disorder not otherwise specified as ascertained by a physician or mental health professional licensed to diagnose.
- Patient is an outpatient and not in imminent need of inpatient hospitalization, or a discharging inpatient with scheduled follow-up with a Behavioral Health psychiatrist.
- Patient has been referred to see a psychiatrist for optimum medication management.
- Patient's Hamilton Depression Rating score is >14
- Ability to read, understand and sign an informed consent document
Exclusion Criteria
- Serious medical illness (as ascertained via the initial triage screening process)
- Patients with a diagnosis of Bipolar I disorder
- Patients with a diagnosis of Schizophrenia or Schizoaffective disorder
- Patients who are legally unable to consent to enrollment in the study (i.e. patients with legal guardians)
Data sourced from ClinicalTrials.gov (NCT01610063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.