DepressionUHSNCT01632267
Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm
An observational study of Depression and Anxiety, run by Assurex Health Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects under the care of a psychiatrist at Union Health Services, Chicago, IL
Who may be able to join
- Major Depressive Disorder
- Dysthymic Disorder
- Depressive Disorder NOS
- Obsessive Compulsive Disorder (OCD)
- Generalized Anxiety Disorder
- Panic Disorder
Show all 9Show fewer
- Anxiety Disorder NOS
- Post-Traumatic Stress Disorder (PTSD)
- Social Phobia
Who cannot join
- Bipolar Disorder
- Schizophrenia
- Schizoaffective Disorder
- Previous pharmacogenomic testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Analysis of Outcomes in Outpatients With Major Depressive Disorder (MDD) in a Staff Model HMO: Pharmacogenetic Algorithm for Psychotropic Pharmacotherapeutic Applications
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.
- Conditions
- Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Depression and anxiety | Subjects with a primary diagnosis of depression or anxiety disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Outpatient Visits
Number of outpatient healthcare visits during study window
Measured: During the one year study window (April 1, 2010 to April 1, 2011)
Secondary outcomes (2)
Number of Medical Absence Days
Number of medical absence days during study window
Measured: During the one year study window (April 1, 2010 to April 1, 2011)
Number of Disability Claims
Number of disabiity claims during study window
Measured: During the one year study window (April 1, 2010 to April 1, 2011)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2012 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assurex Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aida Spahic-Mihajlovic, MD, Principal investigator, Union Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632267
- Sponsor's protocol ID
- 10003
- Acronym
- UHS
- Status last verified
- Feb 2013
- First submitted
- 27 Jun 2012
- Last updated
- 5 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Outcomes in Outpatients With Major Depressive Disorder (MDD) in a Staff Model HMO: Pharmacogenetic Algorithm for Psychotropic Pharmacotherapeutic Applications
- ClinicalTrials.gov ID
- NCT01632267
- Acronym / sponsor ID
- UHS / 10003
- Conditions
- Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Assurex Health Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Jul 2012 (estimated)
- Results
- Posted 22 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depression and anxiety | – | –Subjects with a primary diagnosis of depression or anxiety disorder. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects under the care of a psychiatrist at Union Health Services, Chicago, IL
Key inclusion criteria (9 listed)
- Major Depressive Disorder
- Dysthymic Disorder
- Depressive Disorder NOS
- Obsessive Compulsive Disorder (OCD)
- Generalized Anxiety Disorder
Key exclusion criteria (4 listed)
- Bipolar Disorder
- Schizophrenia
- Schizoaffective Disorder
- Previous pharmacogenomic testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Outpatient Visits
Time frame: During the one year study window (April 1, 2010 to April 1, 2011)
Number of outpatient healthcare visits during study window
2 secondary outcomes
Number of Medical Absence Days
Time frame: During the one year study window (April 1, 2010 to April 1, 2011)
Number of Disability Claims
Time frame: During the one year study window (April 1, 2010 to April 1, 2011)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aida Spahic-Mihajlovic, MD principal investigator
Union Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Assurex Health Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Outpatient Visits (time frame: During the one year study window (April 1, 2010 to April 1, 2011)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.