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DepressionNCT01610063

Evaluation of an Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting

A study testing Pharmacogenomic algorithm in people with Depression, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a study of a genotyping tool that reported on how subjects responded to medications and could be used in a community psychiatry practice to improve medication choice for depression. After the DNA test, an interpretive report was provided to the subjects' physicians. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Depression
What is being tested?
Pharmacogenomic algorithm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
227 participants
Where
1 siteUnited States
Study dates
Jan 2009to May 2013
Phase
Interventional
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 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 as ascertained by a physician or mental health professional licensed to diagnose.
  • Patient is an outpatient and not in imminent need of inpatient hospitalization, or a discharging inpatient with scheduled follow-up with a Behavioral Health psychiatrist.
  • Patient has been referred to see a psychiatrist for optimum medication management.
  • Patient's Hamilton Depression Rating score is >14
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Franciscan Skemp HealthCare

    La Crosse, Wisconsin, 54601

Other trials in United States

About this study

Official title: A Pilot Study for the Evaluation of the Clinic-wide Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting

This was a study of a genotyping tool that reported on how subjects responded to medications and could be used in a community psychiatry practice to improve medication choice for depression. After the DNA test, an interpretive report was provided to the subjects' physicians. The hypothesis of this pilot study was that it was feasible to use this pharmacogenomic algorithm in a new setting to treat depressed subjects..

Read the detailed description

Antidepressant medications are among the most widely prescribed medications. However, only 35% to 45% of depressed patients have a complete remission of their illness when initially treated with these medications. Consequently, the Mayo Clinic psychiatric pharmacogenomic team developed a pharmacogenomic algorithm 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. 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). The trial took place at the Franciscan Skemp Healthcare System in La Crosse, Wisconsin over the course of 12 months.

Conditions
Depression
Being tested
Pharmacogenomic algorithm
Keywords
Algorithm, Depression, Assurex, GeneSight
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacogenomic algorithmOther

    Also called GeneSight

    Genetic test results for 4 genes were put through algorithm and provided to physician for guidance prescribing medication.

Study groups in NCT01610063
Study groupRoleWhat they receive
GuidedExperimentalA pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Receives: Other: Pharmacogenomic algorithm
UnguidedNo interventionTreatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline

    The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.

    Measured: baseline, 8-week visit

Secondary outcomes (7)

  1. Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline

    The HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.

    Measured: baseline, 8-week visit

  2. Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline

    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression. A negative change indicates improvement in the subject's depression symptoms, and a positive change indicates a worsening of the subject's depression symptoms.

    Measured: baseline, 8-week visit

  3. Percentage Change in Outcome by Bin Status and Treatment Group

    The Genesight algorithm presents recommendations for antidepressants and antipsychotics in "bin status" associated with colors. Green indicates "Use as Directed." Yellow indicates "Use with Caution." Red indicates "Use with Increased Caution and with More Frequent Monitoring." Definitions of the depression questionnaires are found in previous outcome measures. A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.

    Measured: baseline, 8-week visit

  4. Pharmacogenomic Report Utilization

    Physicians were directed to complete a survey for each participant detailing their experiences during the study period.

    Measured: baseline, 8-week visit

  5. Physicians' Perception of Participant's Satisfaction With Their Care

    Physicians reported on their perception of each participant's satisfaction with their care only for patients who completed the 8-week study. Physicians were directed to complete a survey for each participant detaining their experience during the study period.

    Measured: 8-week visit

  6. Responders at Week 8

    Definitions of the depression questionnaires are found in previous outcome measures. Definition of responder: a participant who had 50% or higher reduction in psychiatric score from baseline.

    Measured: baseline, 8 weeks

  7. Remitters at Week 8

    Definitions of the depression questionnaires are found in previous outcome measures. Definition of remitter: a participant with score less than or equal to certain value (HAMD-17 <=7, QIDS-C16<=5, PHQ-9<5).

    Measured: baseline, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2012 (estimated)
  2. Study startJan 2009
  3. Primary completionNov 2011
  4. Study completionMay 2013

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01610063
Sponsor's protocol ID
08-005610
Status last verified
Feb 2017
First submitted
25 May 2012
Last updated
30 Mar 2017
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacogenomic algorithm in people with Depression, run by Mayo Clinic 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 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 30 Mar 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?

Yes. Results are posted in the registry (first posted 30 Mar 2017). 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?

Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline (time frame: baseline, 8-week visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01610063.

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 30 Mar 2017.

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