Major Depressive DisorderPhase 4NCT03537547
Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder
A Phase 4 study testing GeneSight Psychotropic test and FDA-approved antidepressant or antipsychotic treatment in people with Major Depressive Disorder and Depression, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study aims to determine whether the GeneSight Psychotropic test can result in better treatment outcomes for patients with treatment-naive major depressive disorder Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Depression, Depressive Disorder
- What is being tested?
- GeneSight Psychotropic test and FDA-approved antidepressant or antipsychotic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2018to 19 Aug 2019
- Phase
- Phase 4
- 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
- Adults 18-65 years of age
- Treatment-naïve major depressive disorder meeting Diagnostic and Statistical Manual 4th Edition (DSM-IV) criteria, without psychosis
- Total baseline score on the Quick Inventory Of Depressive Symptomatology Clinician-rated (QIDS-C16) and the Quick Inventory Of Depressive Symptomatology Self-Report (QIDS-SR16) rating scale ≥11
- Good command of the English language
Who cannot join
- Patients with a current diagnosis of schizophrenia
- Patients with a current diagnosis of schizoaffective disorder
- Patients with a current diagnosis of bipolar disorder (any type)
- Currently meeting DSM-IV criteria for significant substance use disorder (exception: nicotine use disorder)
- A diagnosis of personality disorder that may interfere with the patient's ability to improve on pharmacologic treatment, as determined by study investigator
- Patients currently receiving electroconvulsive therapy(ECT), deep brain stimulation (DBS) or transcranial magnetic stimulation (TMS) treatment
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- History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months
- Significant unstable medical condition; life threatening disease; hepatic insufficiency; liver transplant recipient; cirrhosis of the liver; need for therapies that may obscure the results of treatment and/or of the study; 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
- History of gastric bypass surgery
- Acute suicidal intention and/or in need of immediate hospitalization as judged by the investigator
- Active psychotic symptoms
- Currently in an inpatient facility
- History of prior pharmacogenomic testing
- Currently pregnant or lactating
- Inability to provide informed consent
- Any other factor that in the investigators' judgment may affect patient safety or compliance
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This study aims to determine whether the GeneSight Psychotropic test can result in better treatment outcomes for patients with treatment-naive major depressive disorder
Read the detailed description
Major Depressive Disorder is a chronic psychiatric illness that leads to devastating consequences at the individual and societal levels. Today, the choice of treatment continues to be largely based on subjective factors, primarily the clinician and/or patient's preferences, as well as the individual's history of response to treatment, often tainted by recall bias. Psychiatric medication decisions are even more arbitrary when the subject in question has not had past treatment trials. This often leads to a trial and error process and an increasingly resistant disease with each failed trial. Early implementation of an objective tool designed for tailoring medication choice to an individual may prove highly beneficial in decreasing illness chronicity, individual suffering, and economic burden.
GeneSight Psychotropic test is a pharmacogenomic decision support tool, developed to help clinicians make informed, evidence-based decisions about proper drug selection. Therefore, we propose conducting a randomized, double blind, controlled trial to evaluate the impact of the GeneSight Psychotropic test to guide treatment decisions in patients with treatment-naïve (never having taken medication for depression) Major Depressive Disorder.
This study will involve 6 visits over about 24 weeks where participants will be randomized to have their study clinician have access to their pharmacogenetic report in order to make treatment decisions, or to not have access to their report for the first 12 weeks. At Visit 5, Week 12, all participants will receive a copy of their pharmacogenetics report and all clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks.
- Conditions
- Major Depressive Disorder, Depression, Depressive Disorder, Depressive Episode, Depression, Unipolar
- Being tested
- GeneSight Psychotropic test, FDA-approved antidepressant or antipsychotic treatment
- Keywords
- treatment naive, major depression, pharmacotherapy, pharmacogenomic, genomics
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeneSight Psychotropic testOther
Also called GeneSight test
GeneSight Psychotropic test, developed by AssureRx Health, is a genetic test that analyses pre-selected pharmacokinetics and pharmacodynamics genes and results in a composite phenotype and interpretive report, addressing both safety and efficacy of psychiatric medications.
FDA-approved antidepressant or antipsychotic treatmentDrug
Participant is treated with medications included in the GeneSight Psychotropic product.
| Study group | Role | What they receive |
|---|---|---|
| GeneSight Psychotropic test | Experimental | Participants randomized to have their study clinician have access to their pharmacogenetic report (provided through the GeneSight Psychotropic tool) in order to make treatment decisions for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will continue to be able to use the results to guide treatment options for an additional 12 weeks. Receives: Other: GeneSight Psychotropic test; Drug: FDA-approved antidepressant or antipsychotic treatment |
| Treatment As Usual | Active comparator | Participants randomized to treatment as usual will receive treatment from study clinicians who do not have access to the participant's report for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks. Receives: Drug: FDA-approved antidepressant or antipsychotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression change score- Week 8
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.
Measured: Baseline to Week 8
Secondary outcomes (3)
Hamilton Rating Scale for Depression change score- Week 4
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.
Measured: Baseline to end of week 4
Hamilton Rating Scale for Depression change score- Week 12
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. 17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.
Measured: Baseline to end of week 12
Hamilton Rating Scale for Depression change score- Week 24
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. 17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.
Measured: Baseline to end of week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start4 May 2018
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Why it stopped: Per sponsor and PI institution discussions
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 Washington University School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to have their study clinician have access to their pharmacogenetic report (provide through the GeneSight Psychotropic tool) in order to make treatment decisions, or to not have access to their report for the first 12 weeks. At Visit 5, Week 12, all participants will receive a copy of their pharmacogenetics report and all clinicians will be unblinded for 'open label' to be able to use the results to guide treatment options for an additional 12 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- AssureRx Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Charles Conway, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537547
- Sponsor's protocol ID
- 201609109
- Status last verified
- Jun 2020
- First submitted
- 15 May 2018
- Last updated
- 5 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03537547
- Acronym / sponsor ID
- 201609109
- Conditions
- Major Depressive Disorder, Depression, Depressive Disorder, Depressive Episode, Depression, Unipolar
- Keywords
- treatment naive, major depression, pharmacotherapy, pharmacogenomic, genomics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per sponsor and PI institution discussions
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- AssureRx Health, Inc.
- Study start
- 4 May 2018 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 25 May 2018 (actual)
- 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 study aims to determine whether the GeneSight Psychotropic test can result in better treatment outcomes for patients with treatment-naive major depressive disorder
Detailed description
Major Depressive Disorder is a chronic psychiatric illness that leads to devastating consequences at the individual and societal levels. Today, the choice of treatment continues to be largely based on subjective factors, primarily the clinician and/or patient's preferences, as well as the individual's history of response to treatment, often tainted by recall bias. Psychiatric medication decisions are even more arbitrary when the subject in question has not had past treatment trials. This often leads to a trial and error process and an increasingly resistant disease with each failed trial. Early implementation of an objective tool designed for tailoring medication choice to an individual may prove highly beneficial in decreasing illness chronicity, individual suffering, and economic burden.
GeneSight Psychotropic test is a pharmacogenomic decision support tool, developed to help clinicians make informed, evidence-based decisions about proper drug selection. Therefore, we propose conducting a randomized, double blind, controlled trial to evaluate the impact of the GeneSight Psychotropic test to guide treatment decisions in patients with treatment-naïve (never having taken medication for depression) Major Depressive Disorder.
This study will involve 6 visits over about 24 weeks where participants will be randomized to have their study clinician have access to their pharmacogenetic report in order to make treatment decisions, or to not have access to their report for the first 12 weeks. At Visit 5, Week 12, all participants will receive a copy of their pharmacogenetics report and all clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to have their study clinician have access to their pharmacogenetic report (provide through the GeneSight Psychotropic tool) in order to make treatment decisions, or to not have access to their report for the first 12 weeks. At Visit 5, Week 12, all participants will receive a copy of their pharmacogenetics report and all clinicians will be unblinded for 'open label' to be able to use the results to guide treatment options for an additional 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| GeneSight Psychotropic test | Experimental | Other: GeneSight Psychotropic test, Drug: FDA-approved antidepressant or antipsychotic treatmentParticipants randomized to have their study clinician have access to their pharmacogenetic report (provided through the GeneSight Psychotropic tool) in order to make treatment decisions for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will continue to be able to use the results to guide treatment options for an additional 12 weeks. |
| Treatment As Usual | Active comparator | Drug: FDA-approved antidepressant or antipsychotic treatmentParticipants randomized to treatment as usual will receive treatment from study clinicians who do not have access to the participant's report for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18-65 years of age
- Treatment-naïve major depressive disorder meeting Diagnostic and Statistical Manual 4th Edition (DSM-IV) criteria, without psychosis
- Total baseline score on the Quick Inventory Of Depressive Symptomatology Clinician-rated (QIDS-C16) and the Quick Inventory Of Depressive Symptomatology Self-Report (QIDS-SR16) rating scale ≥11
- Good command of the English language
Key exclusion criteria (16 listed)
- Patients with a current diagnosis of schizophrenia
- Patients with a current diagnosis of schizoaffective disorder
- Patients with a current diagnosis of bipolar disorder (any type)
- Currently meeting DSM-IV criteria for significant substance use disorder (exception: nicotine use disorder)
- A diagnosis of personality disorder that may interfere with the patient's ability to improve on pharmacologic treatment, as determined by study investigator
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 |
|---|---|---|
| GeneSight Psychotropic testAlso: GeneSight testGeneSight Psychotropic test, developed by AssureRx Health, is a genetic test that analyses pre-selected pharmacokinetics and pharmacodynamics genes and results in a composite phenotype and interpretive report, addressing both safety and efficacy of psychiatric medications. | Other | GeneSight Psychotropic test |
| FDA-approved antidepressant or antipsychotic treatmentParticipant is treated with medications included in the GeneSight Psychotropic product. | Drug | GeneSight Psychotropic test, Treatment As Usual |
Primary outcome
Hamilton Rating Scale for Depression change score- Week 8
Time frame: Baseline to Week 8
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.
3 secondary outcomes
Hamilton Rating Scale for Depression change score- Week 4
Time frame: Baseline to end of week 4
Hamilton Rating Scale for Depression change score- Week 12
Time frame: Baseline to end of week 12
Hamilton Rating Scale for Depression change score- Week 24
Time frame: Baseline to end of week 24
Results and safety
The study was stopped early (reason given: Per sponsor and PI institution discussions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
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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.
Charles Conway, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GeneSight Psychotropic test and FDA-approved antidepressant or antipsychotic treatment in people with Major Depressive Disorder and Depression, run by Washington University School of Medicine 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 16 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: stopped early, as of the sponsor's last update on 5 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Per sponsor and PI institution discussions). Results are not available in the source record.
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?
Hamilton Rating Scale for Depression change score- Week 8 (time frame: Baseline to Week 8). 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 5 Jun 2020.