Major Depressive Disorder 1PGx-TIMENCT02474680
Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes
An observational study of Major Depressive Disorder 1, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial summary
This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder 1
- What is being tested?
- Pharmacogenetic testing
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2015to 1 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants must be enrolled in the Avera Care Coordination Program and have insurance coverage through the Avera Health Plans
Who may be able to join
- Must be taking either an anti-depressant or an anti-psychotic medication
- Must provide informed consent
- Must have Avera Health Plans insurance coverage
- Must have three months of participation in the Avera Care Coordination Program
Who cannot join
- Must not be pregnant or breastfeeding
- Must not have an active and/or unstable diagnosis of substance abuse
- Must not have a primary diagnosis of dementia, bulimia, or anorexia nervosa disorder
- Must not have had a previous pharmacogenetic evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Institute for Human Genetics
Sioux Falls, South Dakota, 57108
About this study
This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants.
Read the detailed description
This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants. Retrospective and prospective data will be collected on all subjects before and after pharmacogenetic recommendations have been made. Retrospective data will be collected for the previous 12 months before pharmacogenetic recommendations are made and prospective data will be collected for 12 months after pharmacogenomic recommendations have been made.
- Conditions
- Major Depressive Disorder 1
- Being tested
- Pharmacogenetic testing
- Keywords
- depression, Major Depressive Disorder, MDD, mental health, pharmacogenomics, personalized medicine, precision medicine, anti-depressants
- Medical subject headings
- Major Depressive Disorder 1, Depression, Depressive Disorder, Major, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic testingGenetic
Psychotropic genotyping panel
| Study group | Role | What they receive |
|---|---|---|
| Care Coordination Group | Patients participating in the Avera Care Coordination Program for Intervention 'Pharmacogenetic testing' Receives: Genetic: Pharmacogenetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression scores
Compare depression scores at baseline and following pharmacogenetic-guided medication recommendation
Measured: 12 months
Secondary outcomes (1)
Economic impact of pharmacogenetic testing
Data from patients' insurance provider will be compared pre- and post-pharmacogenetic testing. Such data may include hospitalizations, clinic visits, ER visits, medication expenses, etc.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study start1 Nov 2015
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder 1Studies 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
- Other
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Stanely, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474680
- Sponsor's protocol ID
- AIHG-1420-PGxTIME
- Acronym
- PGx-TIME
- Status last verified
- May 2017
- First submitted
- 5 Feb 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes
- ClinicalTrials.gov ID
- NCT02474680
- Acronym / sponsor ID
- PGx-TIME / AIHG-1420-PGxTIME
- Conditions
- Major Depressive Disorder 1
- Keywords
- depression, Major Depressive Disorder, MDD, mental health, pharmacogenomics, personalized medicine, precision medicine, anti-depressants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants.
Detailed description
This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants. Retrospective and prospective data will be collected on all subjects before and after pharmacogenetic recommendations have been made. Retrospective data will be collected for the previous 12 months before pharmacogenetic recommendations are made and prospective data will be collected for 12 months after pharmacogenomic recommendations have been made.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Care Coordination Group | – | Genetic: Pharmacogenetic testingPatients participating in the Avera Care Coordination Program for Intervention 'Pharmacogenetic testing' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants must be enrolled in the Avera Care Coordination Program and have insurance coverage through the Avera Health Plans
Key inclusion criteria (4 listed)
- Must be taking either an anti-depressant or an anti-psychotic medication
- Must provide informed consent
- Must have Avera Health Plans insurance coverage
- Must have three months of participation in the Avera Care Coordination Program
Key exclusion criteria (4 listed)
- Must not be pregnant or breastfeeding
- Must not have an active and/or unstable diagnosis of substance abuse
- Must not have a primary diagnosis of dementia, bulimia, or anorexia nervosa disorder
- Must not have had a previous pharmacogenetic evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetic testingPsychotropic genotyping panel | Genetic | Care Coordination Group |
Primary outcome
Depression scores
Time frame: 12 months
Compare depression scores at baseline and following pharmacogenetic-guided medication recommendation
1 secondary outcome
Economic impact of pharmacogenetic testing
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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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.
Matthew Stanely, MD principal investigator
Avera McKennan Hospital & University Health Center
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 Major Depressive Disorder 1, run by Avera McKennan Hospital & University Health Center 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 4 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 3 May 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression scores (time frame: 12 months). 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 3 May 2017.