DepressionAMODNCT02286440
A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression
A study testing AssureRx GeneSight genotyping results and Treatment as usual in people with Depression, run by Mayo Clinic at 2 sites in United States.
Trial summary
The overall goal of this investigator-initiated trial is to evaluate the impact of platform algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation on treatment outcome of depression in adolescents. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression
- 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
- 179 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to 6 Feb 2019
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-18, male or female, any race/ethnicity
- Treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
- Major depressive episode diagnosis or bipolar disorder based on KSADS-PL semi-structured psychiatric interview with a severity criteria-40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R)
- Ability to provide informed consent
Who cannot join
- Inability to speak English
- Inability or lack of willingness to provide informed consent and assent.
- Axis I diagnoses: Autism Spectrum Disorder, Anorexia Nervosa, Schizophreniform, and Schizophrenia.
- Psychotropic medication change (including dosage) between screening \& randomization visits.
- Patients who meet DSM 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. Must have at least early, partial or full, remission X 3 months
- Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.
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- Significant unstable medical condition.
- 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.
- Cytochrome (CYP) \& serotonin transporter genomic testing within 5 years.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression (Abbreviation Assurex AMOD)
The overall goal of this investigator-initiated trial is to evaluate the impact of platform algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation on treatment outcome of depression in adolescents. 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 adolescent patients with a moderate to severe major depressive episode defined as a 40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R) will be invited to participate in this study evaluating the GeneSight® platform. This new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, anti-psychotic, and stimulant treatment selection. These patients will have GeneSight® testing and will be randomized to one of two groups. In Group 1 (n=138), GeneSight® testing results will be available to the patient's treating clinician prior to treatment selection. In Group 2 (n=138), testing results will not be available to the patient's research treating clinician. However, all testing results will be made available to all participants and clinicians after the 8-week trial (upon completion of blinded assessments at week 8). The patients and the clinical raters will be blinded to group assignment.
- Conditions
- Depression
- Being tested
- AssureRx GeneSight genotyping results, Treatment as usual
- Keywords
- Depression, Genotyping, Pharmacokinetic, Pharmacodynamic
- Medical subject headings
- Depression
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 test 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.
Baseline to endpoint change in depression
The primary outcome measure is the baseline to endpoint change in the Children's Depression Rating Scale, Revised (CDRS-R).
Measured: 8 weeks
Secondary outcomes (7)
Improvement of depressive symptoms
Quick Inventory of Depressive Symptomatology Adolescent Clinician Rated Form (QIDS-A17 CR)
Measured: 8 weeks
Improvement of depressive symptoms
Quick Inventory of Depressive Symptomatology Adolescent Self-Report (QIDS-A17 SR)
Measured: 8 weeks
Improvement of depressive symptoms
Quick Inventory of Depressive Symptomatology Adolescent Self-Report - Parent [(QIDS-A17 SR (P)
Measured: 8 weeks
Improvement of depressive symptoms
Clinical Global Impression (CGI) scale
Measured: 8 weeks
Improvement of depressive symptoms
Global Assessment Scale (CGAS)
Measured: 8 weeks
Improvement of depressive symptoms
General Behavior Inventory Parent Version (P-GBI) (subscales mania and sleep) Short Form
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 posted7 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul E. Croarkin, Mayo Clinic
- Investigators
- Paul Croarkin, D.O., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286440
- Sponsor's protocol ID
- 14-005547
- Acronym
- AMOD
- Status last verified
- Jun 2020
- First submitted
- 5 Nov 2014
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nooraeen S, Croarkin PE, Geske JR, Shekunov J, Orth SS, Romanowicz M, Frye MA, Vande Voort JL. High Probability of Gene-Drug Interactions Associated with Medication Side Effects in Adolescent Depression: Results from a Randomized Controlled Trial of Pharmacogenetic Testing. J Child Adolesc Psychopharmacol. 2024 Feb;34(1):28-33. doi: 10.1089/cap.2023.0043.
PubMed 38377526Vande Voort JL, Orth SS, Shekunov J, Romanowicz M, Geske JR, Ward JA, Leibman NI, Frye MA, Croarkin PE. A Randomized Controlled Trial of Combinatorial Pharmacogenetics Testing in Adolescent Depression. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):46-55. doi: 10.1016/j.jaac.2021.03.011. Epub 2021 Jun 5.
PubMed 34099307
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. 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 Adolescent Management Of Depression (Abbreviation Assurex AMOD)
- ClinicalTrials.gov ID
- NCT02286440
- Acronym / sponsor ID
- AMOD / 14-005547
- Conditions
- Depression
- Keywords
- Depression, Genotyping, Pharmacokinetic, Pharmacodynamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 7 Nov 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 impact of platform algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation on treatment outcome of depression in adolescents. 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 adolescent patients with a moderate to severe major depressive episode defined as a 40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R) will be invited to participate in this study evaluating the GeneSight® platform. This new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, anti-psychotic, and stimulant treatment selection. These patients will have GeneSight® testing and will be randomized to one of two groups. In Group 1 (n=138), GeneSight® testing results will be available to the patient's treating clinician prior to treatment selection. In Group 2 (n=138), testing results will not be available to the patient's research treating clinician. However, all testing results will be made available to all participants and clinicians after the 8-week trial (upon completion of blinded assessments at week 8). The patients and the clinical raters will be blinded to group assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GeneSight guided treatment | Experimental | Other: AssureRx GeneSight genotyping resultsGeneSight guided group will have their research psychiatrist make treatment recommendations based on test 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
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 13-18, male or female, any race/ethnicity
- Treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
- Major depressive episode diagnosis or bipolar disorder based on KSADS-PL semi-structured psychiatric interview with a severity criteria-40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R)
- Ability to provide informed consent
Key exclusion criteria (10 listed)
- Inability to speak English
- Inability or lack of willingness to provide informed consent and assent.
- Axis I diagnoses: Autism Spectrum Disorder, Anorexia Nervosa, Schizophreniform, and Schizophrenia.
- Psychotropic medication change (including dosage) between screening \& randomization visits.
- Patients who meet DSM 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. 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
Baseline to endpoint change in depression
Time frame: 8 weeks
The primary outcome measure is the baseline to endpoint change in the Children's Depression Rating Scale, Revised (CDRS-R).
7 secondary outcomes
Improvement of depressive symptoms
Time frame: 8 weeks
Improvement of depressive symptoms
Time frame: 8 weeks
Improvement of depressive symptoms
Time frame: 8 weeks
Improvement of depressive symptoms
Time frame: 8 weeks
Improvement of depressive symptoms
Time frame: 8 weeks
Improvement of depressive symptoms
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 16 Jun 2020.
- Derived from this study: PubMed 38377526Nooraeen S, Croarkin PE, Geske JR, Shekunov J, Orth SS, Romanowicz M, Frye MA, Vande Voort JL. High Probability of Gene-Drug Interactions Associated with Medication Side Effects in Adolescent Depression: Results from a Randomized Controlled Trial of Pharmacogenetic Testing. J Child Adolesc Psychopharmacol. 2024 Feb;34(1):28-33. doi: 10.1089/cap.2023.0043.
- Derived from this study: PubMed 34099307Vande Voort JL, Orth SS, Shekunov J, Romanowicz M, Geske JR, Ward JA, Leibman NI, Frye MA, Croarkin PE. A Randomized Controlled Trial of Combinatorial Pharmacogenetics Testing in Adolescent Depression. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):46-55. doi: 10.1016/j.jaac.2021.03.011. Epub 2021 Jun 5.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Paul Croarkin, D.O. principal investigator
Mayo Clinic
2 sites 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, run by Mayo Clinic at 2 sites 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 10 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Baseline to endpoint change in depression (time frame: 8 weeks). 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 NCT02286440, which also lists 2 linked publications.
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 16 Jun 2020; AzTrials last refreshed its copy on 3 Nov 2026.