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Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm

A Retrospective Analysis of Outcomes in Outpatients With Major Depressive Disorder (MDD) in a Staff Model HMO: Pharmacogenetic Algorithm for Psychotropic Pharmacotherapeutic Applications

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01632267
Acronym
UHS
Enrollment
104
Registered
2012-07-02
Start date
2011-01-31
Completion date
2011-09-30
Last updated
2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Brief summary

Antidepressants are among the most widely prescribed medications, yet only 35-45% of patients achieve remission following an initial antidepressant trial. The financial burden of treatment failures in direct treatment costs, disability, decreased productivity, and missed work may in part derive from a mismatch between optimal, and actual, medications prescribed. The present one year retrospective study seeks to evaluate the indirect and direct healthcare costs for 96 patients with a DSM-IV-TR depressive or anxiety disorder, in relation to an interpretive reporting system designed to predict antidepressant responses based on DNA variations in cytochrome P450 genes (CYP2D6, CYP2C19, CYP1A2), the serotonin transporter gene (SLC6A4), and the serotonin 2A receptor (5HTR2A) genes.

Interventions

None listed

Sponsors

Assurex Health Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Major Depressive Disorder * Dysthymic Disorder * Depressive Disorder NOS * Obsessive Compulsive Disorder (OCD) * Generalized Anxiety Disorder * Panic Disorder * Anxiety Disorder NOS * Post-Traumatic Stress Disorder (PTSD) * Social Phobia

Exclusion criteria

* Bipolar Disorder * Schizophrenia * Schizoaffective Disorder * Previous pharmacogenomic testing

Design outcomes

Primary

MeasureTime frameDescription
Number of Outpatient VisitsDuring the one year study window (April 1, 2010 to April 1, 2011)Number of outpatient healthcare visits during study window

Secondary

MeasureTime frameDescription
Number of Medical Absence DaysDuring the one year study window (April 1, 2010 to April 1, 2011)Number of medical absence days during study window
Number of Disability ClaimsDuring the one year study window (April 1, 2010 to April 1, 2011)Number of disabiity claims during study window

Countries

United States

Participant flow

Participants by arm

ArmCount
Depression and Anxiety
Subjects with a primary diagnosis of depression or anxiety disorder.
104
Total104

Baseline characteristics

CharacteristicDepression and Anxiety
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
7 Participants
Age, Categorical
Between 18 and 65 years
97 Participants
Age, Continuous50.9 years
STANDARD_DEVIATION 11.9
Region of Enrollment
United States
104 participants
Sex: Female, Male
Female
68 Participants
Sex: Female, Male
Male
36 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 104
serious
Total, serious adverse events
0 / 104

Outcome results

Primary

Number of Outpatient Visits

Number of outpatient healthcare visits during study window

Time frame: During the one year study window (April 1, 2010 to April 1, 2011)

ArmMeasureValue (MEAN)Dispersion
Depression and AnxietyNumber of Outpatient Visits13 units on a scaleStandard Deviation 9.4
Secondary

Number of Disability Claims

Number of disabiity claims during study window

Time frame: During the one year study window (April 1, 2010 to April 1, 2011)

Secondary

Number of Medical Absence Days

Number of medical absence days during study window

Time frame: During the one year study window (April 1, 2010 to April 1, 2011)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026