DepressionMODNCT02189057
A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management Of Depression
A study testing AssureRx GeneSight genotyping results and Treatment as usual in people with Depression and Mood Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
The overall goal of this investigator-initiated trial is to evaluate the treatment outcome of depression utilizing platform algorithm products that can allow rapid identification of pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Mood Disorder, Bipolar
- What is being tested?
- AssureRx GeneSight genotyping results and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 19 Oct 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65, male or female, any race/ethnicity
- Mayo Clinic Depression Center inpatient or outpatient, or an outpatient of Mayo Clinic Rochester and satellite clinics, and outpatients from Mayo Clinic Health System clinics
- Ability to provide informed consent
- Structured Clinical Interview (SCID) confirmed major depressive episode associated with Major Depressive Disorder, Bipolar I/II disorder, or Schizoaffective Bipolar Disorder
- Current index episode of major depression < 2 years duration
- Moderate symptom severity defined by HAMD-17 rating scale score ≥ 17 [8]
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- Current index episode having not been treated with psychotropic medications or inadequately responsive to treatment (IRT). IRT defined as intolerability, adverse event, or inadequate efficacy of current psychotropic medication (at least 4 weeks duration)
- Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests
- Negative serum or urine pregnancy test (or history of hysterectomy)
- Negative urine toxicology test (will only be completed at the request of the treating clinician).
Who cannot join
- Inability to speak English
- Inability or lack of willingness to provide informed consent
- Axis I or II disorder other than depression (i.e., by clinical assessment) that is the primary reason for treatment
- Psychotropic medication change (including dosage) between screening \& baseline visit with exception of no more than 8mg of Ativan within a 24-hour period.
- Patients who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for any significant current substance use disorder other than nicotine or caffeine. Must have at least early, partial or full, remission X 3 months
- Clinically diagnosed cannabis use disorder, or SCID confirmed cannabis abuse or dependence.
Show all 18Show fewer
- Current clinical diagnosis delirium, dementia, other cognitive disorders, or non-mood psychotic disorder (i.e., schizophrenia, delusional disorder)
- Index episode symptoms of hallucinations or delusions
- Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator
- History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 6 months
- Significant unstable medical condition
- Hepatic insufficiency (2.5 X upper limit of normal (ULN) for Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ), past liver transplant recipient, and/or clinical diagnosis of cirrhosis of the liver
- Malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications
- Participation in another clinical trial within 30 days of the screening visit
- Anticipated inability to attend scheduled study visits
- Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol
- Known cytochrome (CYP) \& serotonin transporter genomic testing results within 5 years
- A score of ≥15 on the Young Mania Rating Scale (YMRS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management of Depression
The overall goal of this investigator-initiated trial is to evaluate the treatment outcome of depression utilizing platform algorithm products that can allow rapid identification of pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence.
Read the detailed description
Treatment seeking depressed patients (SCID confirmed major depressive disorder or bipolar I/II disorder) to the Mayo Clinic Depression Center will be invited to participate in this study evaluating the Assurex GeneSight® platform; this new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, antipsychotic, and stimulant associated treatment outcomes for depression. This study will recruit treatment seeking patients with major depression with an index episode of moderate symptom severity that has been unresponsive or poorly tolerated to at least one prior antidepressant treatment. This will be an 8-week, double-blind trial where depressed patients are randomized to testing results of GeneSight® (tricolored clinical report) prior to treatment selection (n=138) vs. treatment as usual (tricolored dummy report) (n=138). All testing results will be made available after the 8-week trial.
- Conditions
- Depression, Mood Disorder, Bipolar
- Being tested
- AssureRx GeneSight genotyping results, Treatment as usual
- Keywords
- Bipolar, Unipolar, Genotyping, Pharmacokinetic, Pharmacodynamic
- Medical subject headings
- Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssureRx GeneSight genotyping resultsOther
Treatment as usualOther
| Study group | Role | What they receive |
|---|---|---|
| GeneSight guided treatment | Experimental | GeneSight guided group will have their research psychiatrist make treatment recommendations based on AssureRx GeneSight genotyping results. Receives: Other: AssureRx GeneSight genotyping results |
| Treatment as usual group | Active comparator | Treatment as usual group will have treatment recommendations based on clinical judgment Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression as measured by the Quick Inventory of Depressive Symptoms (QIDS-C16)
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 weeks
Secondary outcomes (5)
Number of subjects with improvement of depressive symptoms as shown by 50% reduction in QIDS-C16 score
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: 8 weeks
Number of subjects with improvement of depressive symptoms as shown by a score <6 on QIDS-C16
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: 8 weeks
Number of subjects with improvement of depressive symptoms as shown by score of "much" or "very much improved" on Clinical Global Impression - Improvement Scale
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1. Very much improved, 2. Much improved, 3. Minimally improved, 4. No change, 5. Minimally worse, 6. Much worse, 7. Very much worse
Measured: 8 weeks
Improvement of depressive symptoms as shown by the Hamilton Rating Scale for Depression (HAMD-17)
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: 8 weeks
Improvement of depressive symptoms
Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention.
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 posted14 Jul 2014 (estimated)
- Study startNov 2014
- Primary completion19 Oct 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized to either genotyping intervention or treatment as usual.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Frye, Mayo Clinic
- Investigators
- Mark Frye, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189057
- Sponsor's protocol ID
- 13-007981
- Acronym
- MOD
- Status last verified
- Oct 2018
- First submitted
- 8 Jul 2014
- Last updated
- 22 Oct 2018
- 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 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management of Depression
- ClinicalTrials.gov ID
- NCT02189057
- Acronym / sponsor ID
- MOD / 13-007981
- Conditions
- Depression, Mood Disorder, Bipolar
- Keywords
- Bipolar, Unipolar, Genotyping, Pharmacokinetic, Pharmacodynamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 14 Jul 2014 (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 overall goal of this investigator-initiated trial is to evaluate the treatment outcome of depression utilizing platform algorithm products that can allow rapid identification of pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence.
Detailed description
Treatment seeking depressed patients (SCID confirmed major depressive disorder or bipolar I/II disorder) to the Mayo Clinic Depression Center will be invited to participate in this study evaluating the Assurex GeneSight® platform; this new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, antipsychotic, and stimulant associated treatment outcomes for depression. This study will recruit treatment seeking patients with major depression with an index episode of moderate symptom severity that has been unresponsive or poorly tolerated to at least one prior antidepressant treatment. This will be an 8-week, double-blind trial where depressed patients are randomized to testing results of GeneSight® (tricolored clinical report) prior to treatment selection (n=138) vs. treatment as usual (tricolored dummy report) (n=138). All testing results will be made available after the 8-week trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomized to either genotyping intervention or treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| GeneSight guided treatment | Experimental | Other: AssureRx GeneSight genotyping resultsGeneSight guided group will have their research psychiatrist make treatment recommendations based on AssureRx GeneSight genotyping results. |
| Treatment as usual group | Active comparator | Other: Treatment as usualTreatment as usual group will have treatment recommendations based on clinical judgment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-65, male or female, any race/ethnicity
- Mayo Clinic Depression Center inpatient or outpatient, or an outpatient of Mayo Clinic Rochester and satellite clinics, and outpatients from Mayo Clinic Health System clinics
- Ability to provide informed consent
- Structured Clinical Interview (SCID) confirmed major depressive episode associated with Major Depressive Disorder, Bipolar I/II disorder, or Schizoaffective Bipolar Disorder
- Current index episode of major depression < 2 years duration
Key exclusion criteria (18 listed)
- Inability to speak English
- Inability or lack of willingness to provide informed consent
- Axis I or II disorder other than depression (i.e., by clinical assessment) that is the primary reason for treatment
- Psychotropic medication change (including dosage) between screening \& baseline visit with exception of no more than 8mg of Ativan within a 24-hour period.
- Patients who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for any significant current substance use disorder other than nicotine or caffeine. Must have at least early, partial or full, remission X 3 months
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 |
|---|---|---|
| AssureRx GeneSight genotyping results | Other | GeneSight guided treatment |
| Treatment as usual | Other | Treatment as usual group |
Primary outcome
Change in depression as measured by the Quick Inventory of Depressive Symptoms (QIDS-C16)
Time frame: baseline, 8 weeks
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.
5 secondary outcomes
Number of subjects with improvement of depressive symptoms as shown by 50% reduction in QIDS-C16 score
Time frame: 8 weeks
Number of subjects with improvement of depressive symptoms as shown by a score <6 on QIDS-C16
Time frame: 8 weeks
Number of subjects with improvement of depressive symptoms as shown by score of "much" or "very much improved" on Clinical Global Impression - Improvement Scale
Time frame: 8 weeks
Improvement of depressive symptoms as shown by the Hamilton Rating Scale for Depression (HAMD-17)
Time frame: 8 weeks
Improvement of depressive symptoms
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 22 Oct 2018.
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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.
Mark Frye, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AssureRx GeneSight genotyping results and Treatment as usual in people with Depression and Mood Disorder, 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 10 inclusion and 18 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 22 Oct 2018. 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?
Change in depression as measured by the Quick Inventory of Depressive Symptoms (QIDS-C16) (time frame: baseline, 8 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 22 Oct 2018.