Major Depressive DisorderPGX-AMGNCT02443584
Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis
A study testing pharmacogenetic testing in people with Major Depressive Disorder, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial summary
This is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- pharmacogenetic testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 1 Apr 2017
- Phase
- Interventional
- 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
Who may be able to join
- Current primary or secondary diagnosis of Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
- Have moderate to severe depression as identified by PHQ-9 scoring of 10 or greater
- Taking or be newly prescribed an anti-depressant or anti-psychotic medication
- Able to provide informed consent
Who cannot join
- Pregnant or breastfeeding
- Active and/or unstable diagnosis of substance abuse, excluding nicotine
- Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schioaffective disorder, or personality disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105
About this study
Official title: Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified With Avera Medical Group Clinics
This is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS).
Read the detailed description
Mental illness affects one in four adults in the United States; approximately 61.5 million Americans experience mental illness in a given year. According to the National Alliance for the Mentally Ill, the impact of serious mental illness costs Americans $193.2 billion in lost earnings per year. In addition, mental illness patients have an increased risk of having chronic medical conditions, leading to increased costs and emergency service utilization for those conditions. In addition to substantial costs, patients with psychiatric illness are difficult to treat. More than two-thirds of patients with depression do not respond to first line therapy. Treatment often involves numerous trials of individual agents and combinations of medications in order to achieve optimal response. Pharmacogenetic testing is being used in more settings to guide treatment decisions.
- Conditions
- Major Depressive Disorder
- Being tested
- pharmacogenetic testing
- Keywords
- depression, pharmacogenetics, pharmacogenomics, major depressive disorder, genetics, anti-depressants
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacogenetic testingOther
pharmacogenetic testing for anti-depressant/anti-psychotic medications
| Study group | Role | What they receive |
|---|---|---|
| 4-Week Group | Other | Pharmacogenetic testing released to physician at 4 weeks following enrollment into study Receives: Other: pharmacogenetic testing |
| 12-Week Group | Other | Pharmacogenetic testing released to physician at 12 weeks following enrollment into study Receives: Other: pharmacogenetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing)
response to medication following medication recommendation guided by pharmacogenetic testing
Measured: 24 weeks
Secondary outcomes (1)
Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing)
Utilization by physicians in following medication recommendations guided by pharmacogenetic testing
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study start1 Feb 2015
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- 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 Stanley, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443584
- Sponsor's protocol ID
- AIHG-1430-PGxAMG
- Acronym
- PGX-AMG
- Status last verified
- May 2017
- First submitted
- 6 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
- Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified With Avera Medical Group Clinics
- ClinicalTrials.gov ID
- NCT02443584
- Acronym / sponsor ID
- PGX-AMG / AIHG-1430-PGxAMG
- Conditions
- Major Depressive Disorder
- Keywords
- depression, pharmacogenetics, pharmacogenomics, major depressive disorder, genetics, anti-depressants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 14 May 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 randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS).
Detailed description
Mental illness affects one in four adults in the United States; approximately 61.5 million Americans experience mental illness in a given year. According to the National Alliance for the Mentally Ill, the impact of serious mental illness costs Americans $193.2 billion in lost earnings per year. In addition, mental illness patients have an increased risk of having chronic medical conditions, leading to increased costs and emergency service utilization for those conditions. In addition to substantial costs, patients with psychiatric illness are difficult to treat. More than two-thirds of patients with depression do not respond to first line therapy. Treatment often involves numerous trials of individual agents and combinations of medications in order to achieve optimal response. Pharmacogenetic testing is being used in more settings to guide treatment decisions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-Week Group | Other | Other: pharmacogenetic testingPharmacogenetic testing released to physician at 4 weeks following enrollment into study |
| 12-Week Group | Other | Other: pharmacogenetic testingPharmacogenetic testing released to physician at 12 weeks following enrollment into study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current primary or secondary diagnosis of Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
- Have moderate to severe depression as identified by PHQ-9 scoring of 10 or greater
- Taking or be newly prescribed an anti-depressant or anti-psychotic medication
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding
- Active and/or unstable diagnosis of substance abuse, excluding nicotine
- Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schioaffective disorder, or personality disorder
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 testingpharmacogenetic testing for anti-depressant/anti-psychotic medications | Other | 12-Week Group, 4-Week Group |
Primary outcome
Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing)
Time frame: 24 weeks
response to medication following medication recommendation guided by pharmacogenetic testing
1 secondary outcome
Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing)
Time frame: 24 weeks
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 Stanley, 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?
A study testing pharmacogenetic testing in people with Major Depressive Disorder, 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 3 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?
Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing) (time frame: 24 weeks). 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.