DepressionNCT04355650
Augmented Human Intelligence in Major Depressive Disorder
A study testing Clinical decision support tool in people with Depression and Major Depressive Disorder, run by Mayo Clinic at 2 sites in United States.
Trial summary
Researchers are testing whether a computer program (called a clinical decision support tool) can help clinicians predict how a patient with depression will respond to antidepressant medication. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression, Major Depressive Disorder
- What is being tested?
- Clinical decision support tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2020to 2 Dec 2022
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Outpatients with nonpsychotic MDD. Outpatient status assumes that the subject is not psychiatrically hospitalized or in an active suicidal crisis requiring hospitalization.
- A total score of >10 on the QIDS-CR and on the QIDS-SR (equivalent to a HAMD17 score of 13 [ids-qids.org, accessed on April 12, 2019]) given that when medication exceeds the effect of placebo in primary care, participants have a 17-item HAMD score >12. We added 2 HAMD points to take into account the possibility of measurement error. This is a very similar approach taken to the successful recruitment of subjects into the PGRN-AMPS trial.
- Antidepressant treatment is deemed appropriate by the study clinician.
- Adults who are between 18-64 years of age.
- Ability to provide informed consent
- Ability to understand English
Who cannot join
- A medical contraindication that precludes SSRI or SNRI treatment.
- Presence of a general medical condition that, in the opinion of this study clinician, is the cause of their depressive symptoms, will be exclusionary.
- People with treatment-resistant depression will be excluded from participating. For this study, treatment resistance will be defined as failure to respond to two or more adequate therapeutic trials of SSRIs and at least on SNRI therapeutic trial (sufficient antidepressant dose, for 6 weeks or longer) during the current depressive episode. Failure to tolerate a therapeutic trial of a given medication (resulting in discontinuation due to adverse effects) will not be counted as exclusionary. Persons who have failed to respond to two or more adequately designed and executed therapeutic trials of SSRIs but have no history of least one failure to respond to SNRI treatment during the current depressive episode will be eligible to receive treatment with an SNRI in this study.
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar I or II disorder, or bipolar disorder NOS (including other specified or other unspecified bipolar disorders) or a primary psychiatric condition that requires a different initial treatment than an antidepressant.
- Currently taking an antidepressant medication with subtherapeutic results in terms of antidepressive efficacy and unwilling to undergo a medication taper and discontinuation prior to initiation of a study drug from this protocol. The subject will be closely monitored by the study clinician during the medication taper and discontinuation phase. The design of the medication taper will be at the discretion of the study clinician. Subjects who cannot be safely tapered from their medication or who experience adverse effects during the taper that make further tapering infeasible will be excluded from the study.
- Use of antidepressant medication primarily for management of nicotine dependence, chronic pain, migraine prophylaxis or other diagnoses.
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- Active substance use disorder. Persons in sustained full remission (> 12 months) and a negative urine drug of abuse screen at the screening visit will be considered eligible. Note: An additional urine drug screen will not be necessary for individuals with a negative urine drug screen documented in the medical record where the date of testing occurred within 12 weeks (84 days) of the screening/baseline study visit. However, study clinicians can still obtain a urine drug screen based on their clinical judgement even in participants with a negative drug screen within the 12 weeks preceding the screening/baseline study visit.
- Trazodone, melatonin, low-dose quetiapine (<100 mg QHS), z-drugs (zolpidem, zopiclone, eszopiclone, etc.), ramelteon, and diphenhydramine may be used as rescue medications for insomnia. Benzodiazepines may be used for treatment of anxiety, and atomoxetine may be used for the treatment of attention deficit disorder. Study subjects currently on antipsychotic medications (e.g., typical and atypical antipsychotic drugs, other than low-dose quetiapine for insomnia) and mood stabilizing agents (e.g., lithium, carbamazepine, valproate, lamotrigine) are not eligible for the study
- Pregnant subjects and those who are currently breastfeeding and who plan to continue breastfeeding will be excluded.
- Persons currently undergoing ECT, TMS or DBS as acute series or for maintenance.
- Patients currently psychiatrically hospitalized or in an active suicidal crisis requiring hospitalization in the opinion of the study clinician.
- Individuals whose total QIDS-CR and total QIDS-SR scores are 10 or higher at the screening visit but decrease (improve) to total scores less than 10 on either the QIDS-CR or QIDS-SR at the baseline visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Clinical Pilot of Augmented Human Intelligence in Major Depressive Disorder (AHI/Depression Pilot)
Researchers are testing whether a computer program (called a clinical decision support tool) can help clinicians predict how a patient with depression will respond to antidepressant medication.
- Conditions
- Depression, Major Depressive Disorder
- Being tested
- Clinical decision support tool
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support toolOther
Adults (aged 18-64 years) who meet DSM-5 diagnostic criteria for non-psychotic unipolar major depressive disorder (MDD) and meet study eligibility criteria will receive 8 weeks of open-label treatment with an SSRI or SNRI antidepressant. Depressive symptoms will be assessed using the subject- and clinician-rated versions of the 16-items QIDS scale (QIDS-SR and QIDS-CR) and the 17-item HAMD at baseline, week 2 (via telephone), week 4, and week 8; with an additional phone contact at week 24. The QIDS scale scores at 2- and 4-weeks will be entered into the AHI-based clinical decision support tool, and the outcome predicted by the tool (e.g., the predicted eventual treatment outcome at 8 weeks) will be recorded. Clinicians and patients will be blinded to the clinical decision support tool prediction of outcome provided at the 2- and 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Clinical decision tool | Experimental | Launch of clinical decision support tool at baseline visit with study clinician. Receives: Other: Clinical decision support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed clinical outcomes compared to predicted outcome at 2 week follow up
Evaluate the degree of statistical concordance between observed clinical outcomes (non-response/remission) after 8 weeks of treatment and the outcomes predicted by an AHI-based clinical decision support tool after 2 weeks of follow up (i.e., concordance between 2-week predicted outcome and 8-week observed outcome), as assessed using the QIDS-SR and QIDS-CR, in adults with DSM-5-defined MDD who receive prospective treatment with an SSRI or SNRI antidepressant.
Measured: Baseline to 2 week visit
Secondary outcomes (1)
Observed clinical outcomes compared to predicted outcome at 4 week follow up
Evaluate the degree of statistical concordance between observed clinical outcomes (non-response/remission) after 8 weeks of treatment and the outcomes predicted by an AHI-based clinical decision support tool after 4 weeks of follow up (i.e., concordance between 4-week predicted outcome and 8-week observed outcome), as assessed using the QIDS-SR and QIDS-CR, in adults with DSM-5-defined MDD who receive prospective treatment with an SSRI or SNRI antidepressant.
Measured: Baseline to 4 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start27 Jan 2020
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William V. Bobo, M.D., Mayo Clinic
- Investigators
- William V Bobo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355650
- Sponsor's protocol ID
- 19-005341
- Status last verified
- Dec 2022
- First submitted
- 17 Apr 2020
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pilot of Augmented Human Intelligence in Major Depressive Disorder (AHI/Depression Pilot)
- ClinicalTrials.gov ID
- NCT04355650
- Acronym / sponsor ID
- 19-005341
- Conditions
- Depression, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 21 Apr 2020 (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.
Researchers are testing whether a computer program (called a clinical decision support tool) can help clinicians predict how a patient with depression will respond to antidepressant medication.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical decision tool | Experimental | Other: Clinical decision support toolLaunch of clinical decision support tool at baseline visit with study clinician. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Outpatients with nonpsychotic MDD. Outpatient status assumes that the subject is not psychiatrically hospitalized or in an active suicidal crisis requiring hospitalization.
- A total score of >10 on the QIDS-CR and on the QIDS-SR (equivalent to a HAMD17 score of 13 [ids-qids.org, accessed on April 12, 2019]) given that when medication exceeds the effect of placebo in primary care, participants have a 17-item HAMD score >12. We added 2 HAMD points to take into account the possibility of measurement error. This is a very similar approach taken to the successful recruitment of subjects into the PGRN-AMPS trial.
- Antidepressant treatment is deemed appropriate by the study clinician.
- Adults who are between 18-64 years of age.
- Ability to provide informed consent
Key exclusion criteria (12 listed)
- A medical contraindication that precludes SSRI or SNRI treatment.
- Presence of a general medical condition that, in the opinion of this study clinician, is the cause of their depressive symptoms, will be exclusionary.
- People with treatment-resistant depression will be excluded from participating. For this study, treatment resistance will be defined as failure to respond to two or more adequate therapeutic trials of SSRIs and at least on SNRI therapeutic trial (sufficient antidepressant dose, for 6 weeks or longer) during the current depressive episode. Failure to tolerate a therapeutic trial of a given medication (resulting in discontinuation due to adverse effects) will not be counted as exclusionary. Persons who have failed to respond to two or more adequately designed and executed therapeutic trials of SSRIs but have no history of least one failure to respond to SNRI treatment during the current depressive episode will be eligible to receive treatment with an SNRI in this study.
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar I or II disorder, or bipolar disorder NOS (including other specified or other unspecified bipolar disorders) or a primary psychiatric condition that requires a different initial treatment than an antidepressant.
- Currently taking an antidepressant medication with subtherapeutic results in terms of antidepressive efficacy and unwilling to undergo a medication taper and discontinuation prior to initiation of a study drug from this protocol. The subject will be closely monitored by the study clinician during the medication taper and discontinuation phase. The design of the medication taper will be at the discretion of the study clinician. Subjects who cannot be safely tapered from their medication or who experience adverse effects during the taper that make further tapering infeasible will be excluded from the study.
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 |
|---|---|---|
| Clinical decision support toolAdults (aged 18-64 years) who meet DSM-5 diagnostic criteria for non-psychotic unipolar major depressive disorder (MDD) and meet study eligibility criteria will receive 8 weeks of open-label treatment with an SSRI or SNRI antidepressant. Depressive symptoms will be assessed using the subject- and clinician-rated versions of the 16-items QIDS scale (QIDS-SR and QIDS-CR) and the 17-item HAMD at baseline, week 2 (via telephone), week 4, and week 8; with an additional phone contact at week 24. The QIDS scale scores at 2- and 4-weeks will be entered into the AHI-based clinical decision support tool, and the outcome predicted by the tool (e.g., the predicted eventual treatment outcome at 8 weeks) will be recorded. Clinicians and patients will be blinded to the clinical decision support tool prediction of outcome provided at the 2- and 4 weeks. | Other | Clinical decision tool |
Primary outcome
Observed clinical outcomes compared to predicted outcome at 2 week follow up
Time frame: Baseline to 2 week visit
Evaluate the degree of statistical concordance between observed clinical outcomes (non-response/remission) after 8 weeks of treatment and the outcomes predicted by an AHI-based clinical decision support tool after 2 weeks of follow up (i.e., concordance between 2-week predicted outcome and 8-week observed outcome), as assessed using the QIDS-SR and QIDS-CR, in adults with DSM-5-defined MDD who receive prospective treatment with an SSRI or SNRI antidepressant.
1 secondary outcome
Observed clinical outcomes compared to predicted outcome at 4 week follow up
Time frame: Baseline to 4 week visit
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 12 Dec 2022.
- 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.
William V Bobo, MD 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 Clinical decision support tool in people with Depression and Major Depressive Disorder, 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 6 inclusion and 12 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 12 Dec 2022. 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?
Observed clinical outcomes compared to predicted outcome at 2 week follow up (time frame: Baseline to 2 week visit). 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 12 Dec 2022.