Major Depressive DisorderHAMMNCT02479464
Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Therapy-based Clinical Setting
A study testing Genotyping results in people with Major Depressive Disorder, run by Mayo Clinic.
Trial summary
The Mayo Clinic psychiatric pharmacogenomic team has developed a pharmacogenomic algorithm that has been designed to improve the effectiveness and safety of antidepressant medications by providing guidance in medication selection and appropriate dosing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Genotyping results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Aug 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is between the ages of 18 and 80.
- Major depressive disorder or depressive disorder not otherwise specified (NOS) as ascertained by a physician or mental health professional licensed to diagnose.
- Patient is an outpatient and not in imminent need of inpatient hospitalization
- Patient's Hamilton Depression Rating score is >14
- Patient is being seen by a psychiatrist for optimum medication management.
- Ability to read, understand and sign an informed consent document
Who cannot join
- 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)
About this study
Official title: A Pilot Study for the Evaluation of the Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Therapy-based Clinical Setting
The Mayo Clinic psychiatric pharmacogenomic team has developed a pharmacogenomic algorithm that has been designed to improve the effectiveness and safety of antidepressant medications by providing guidance in medication selection and appropriate dosing. This algorithm has been incorporated into a new genotyping interpretative report. This report is now available from AssureRx. The pharmacogenomic algorithm is based on genotyping both copies of four informative genes. These four genes are: 1) the Cytochrome P450 2D6 gene; 2) the Cytochrome P450 2C19 gene; 3) the Serotonin Transporter gene (SLC6A4); and 4) the Serotonin 2A receptor gene (5HTR2A). Though this algorithm is not yet part of the universal standard of care, Mayo clinicians have found it helpful in guiding treatment decisions at Mayo Clinic Rochester.
Read the detailed description
The proposed pilot study is designed to evaluate the clinical impact of the interpretive report in an outpatient behavioral health clinic in St. Paul, Minnesota. While the ultimate goal of this project is to show an improvement in patient outcomes, this pilot study will be used to evaluate the feasibility of introducing the pharmacogenomic algorithm to a new setting that does not routinely use the algorithm. Secondary outcome data will be collected to generate meaningful estimates of the magnitude of potential treatment effects. The study will consist of two phases, each enrolling 2530 subjects. In Phase 1, consecutive patients will be prospectively monitored to observe standard practice. Patients will be given the option to receive genotyping and those that agree will have blood drawn. However, the results of the genotyping and algorithm will not be released until all phase 1 patients have completed study visits.. Subsequently, in Phase 2, also enrolling 3025 subjects, the results of the genotyping and algorithm will be made available immediately for additional consecutive prospectively monitored patients. Patients will be prospectively monitored in the same fashion as Phase 1. The results of the study will be used to perform preliminary analyses and subsequent fully powered multi-site trials will be planned based on the results of this study.
- Conditions
- Major Depressive Disorder
- Being tested
- Genotyping results
- Keywords
- AssureRx, Algorithm, Major depressive disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotyping resultsGenetic
Genotyping results provided in Phase II
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | No intervention | This is the treatment as usual arm to monitor the current standard clinical practice |
| Part 2 | Other | This group will be provided with genotyping results after baseline visit to guide clinical medication management Receives: Genetic: Genotyping results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients approached who consent to use of pharmacogenomic algorithm
Measured: 8 weeks
Amount of time from ordering test to receipt of results
Measured: 8 weeks
Proportion of time that the physician prescribed a medication that was recommended by the algorithm
Measured: 8 weeks
Secondary outcomes (6)
Time to remission of depressive symptoms
Hamilton rating of < 7
Measured: 8 weeks
Measured side effect burden
Reduction in Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score.
Measured: 8 weeks
Number of participants who change their initial medication regimen
Measured: 8 weeks
Health care clinical cost
defined by analysis of mental health resource utilization
Measured: 8 weeks
Physician satisfaction with delivery of clinical care
defined by researcher developed Likert-based satisfaction survey
Measured: 8 weeks
Patient satisfaction with clinical care
defined by researcher developed Likert-based satisfaction survey
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionAug 2014
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- AssureRx Health, Inc.
- Responsible party
- Principal investigator, Daniel K. Hall-Flavin, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479464
- Sponsor's protocol ID
- 09-002523
- Acronym
- HAMM
- Status last verified
- May 2019
- First submitted
- 16 Jun 2015
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Evaluation of the Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Therapy-based Clinical Setting
- ClinicalTrials.gov ID
- NCT02479464
- Acronym / sponsor ID
- HAMM / 09-002523
- Conditions
- Major Depressive Disorder
- Keywords
- AssureRx, Algorithm, Major depressive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- AssureRx Health, Inc.
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 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.
The Mayo Clinic psychiatric pharmacogenomic team has developed a pharmacogenomic algorithm that has been designed to improve the effectiveness and safety of antidepressant medications by providing guidance in medication selection and appropriate dosing. This algorithm has been incorporated into a new genotyping interpretative report. This report is now available from AssureRx. The pharmacogenomic algorithm is based on genotyping both copies of four informative genes. These four genes are: 1) the Cytochrome P450 2D6 gene; 2) the Cytochrome P450 2C19 gene; 3) the Serotonin Transporter gene (SLC6A4); and 4) the Serotonin 2A receptor gene (5HTR2A). Though this algorithm is not yet part of the universal standard of care, Mayo clinicians have found it helpful in guiding treatment decisions at Mayo Clinic Rochester.
Detailed description
The proposed pilot study is designed to evaluate the clinical impact of the interpretive report in an outpatient behavioral health clinic in St. Paul, Minnesota. While the ultimate goal of this project is to show an improvement in patient outcomes, this pilot study will be used to evaluate the feasibility of introducing the pharmacogenomic algorithm to a new setting that does not routinely use the algorithm. Secondary outcome data will be collected to generate meaningful estimates of the magnitude of potential treatment effects. The study will consist of two phases, each enrolling 2530 subjects. In Phase 1, consecutive patients will be prospectively monitored to observe standard practice. Patients will be given the option to receive genotyping and those that agree will have blood drawn. However, the results of the genotyping and algorithm will not be released until all phase 1 patients have completed study visits.. Subsequently, in Phase 2, also enrolling 3025 subjects, the results of the genotyping and algorithm will be made available immediately for additional consecutive prospectively monitored patients. Patients will be prospectively monitored in the same fashion as Phase 1. The results of the study will be used to perform preliminary analyses and subsequent fully powered multi-site trials will be planned based on the results of this study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | No intervention | –This is the treatment as usual arm to monitor the current standard clinical practice |
| Part 2 | Other | Genetic: Genotyping resultsThis group will be provided with genotyping results after baseline visit to guide clinical medication management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is between the ages of 18 and 80.
- Major depressive disorder or depressive disorder not otherwise specified (NOS) as ascertained by a physician or mental health professional licensed to diagnose.
- Patient is an outpatient and not in imminent need of inpatient hospitalization
- Patient's Hamilton Depression Rating score is >14
- Patient is being seen by a psychiatrist for optimum medication management.
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| Genotyping resultsGenotyping results provided in Phase II | Genetic | Part 2 |
Primary outcome
Percentage of patients approached who consent to use of pharmacogenomic algorithm
Time frame: 8 weeks
Amount of time from ordering test to receipt of results
Time frame: 8 weeks
Proportion of time that the physician prescribed a medication that was recommended by the algorithm
Time frame: 8 weeks
6 secondary outcomes
Time to remission of depressive symptoms
Time frame: 8 weeks
Measured side effect burden
Time frame: 8 weeks
Number of participants who change their initial medication regimen
Time frame: 8 weeks
Health care clinical cost
Time frame: 8 weeks
Physician satisfaction with delivery of clinical care
Time frame: 8 weeks
Patient satisfaction with clinical care
Time frame: 8 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 21 May 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Genotyping results in people with Major Depressive Disorder, run by Mayo Clinic.
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 6 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 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of patients approached who consent to use of pharmacogenomic algorithm (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 21 May 2019.