Major Depressive DisorderPhase 4LEAP-DBNCT04388189
Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion
A Phase 4 study testing Duloxetine and Bupropion in people with Major Depressive Disorder, run by Alto Neuroscience.
Trial summary
The LEAP-DB study will be conducted to validate the utility of EEG biomarkers as an aid to antidepressant treatment selection in adults with MDD. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Duloxetine and Bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2020to 30 May 2023
- 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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 22 or older at the time of informed consent.
- Diagnosis of Major Depressive Disorder (MDD) based on the Structured Clinical Interview for DSM-5 for depression.
- Moderate or severe depression on DSM-5 depression criteria items, as assessed by a score of 10 or more on the Patient Health Questionnaire (PHQ-9)
- Has not taken either study medications (duloxetine, bupropion) in the current episode
- Has not received electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or esketamine treatment in the current episode
- Provision of personally signed and dated written informed consent prior to any study procedures
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- Agrees to, and is eligible for all biomarker assessments (EEG, neurocognitive testing, activity and sleep monitoring, genetic testing)
- Fluent in English
- Ability to complete all assessments independently
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Diagnosis of bipolar disorder or a psychotic disorder based on the Structured Clinical Interview for DSM-5.
- Concurrent use of antipsychotics or mood stabilizers
- Use of hypnotics, anxiolytics or opiate pain medications greater than three days per week and unable to reduce use to three or fewer days per week on an as needed basis
- Pregnant or breastfeeding
- Severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks
- Active substance use that interferes with ability to consent and/or complete assessments
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- Any contraindication to EEG (e.g. requiring high concentration oxygen)
- Employees/family of employees of clinic site
- Participation in another research study that began within less than 2 months prior to the first study visit
About this study
Official title: Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion (LEAP-DB): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Duloxetine Versus Bupropion in Adults With Major Depressive Disorder
The LEAP-DB study will be conducted to validate the utility of EEG biomarkers as an aid to antidepressant treatment selection in adults with MDD.
Read the detailed description
The LEAP-DB study is an 8-week, multicenter, randomized, blinded study to evaluate the performance of EEG-based biomarkers in predicting treatment outcome. Study participants will be randomized in a 1:1 ratio to receive either duloxetine or bupropion and followed for 8 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- Duloxetine, Bupropion
- Keywords
- Major Depressive Disorder, EEG, Biomarker, Antidepressant, Duloxetine, Bupropion
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
FDA approved antidepressant
BupropionDrug
Also called Wellbutrin
FDA approved antidepressant
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Duloxetine 60 mg daily for 8 weeks Receives: Drug: Duloxetine |
| Bupropion | Active comparator | Bupropion 150-450 mg daily for 8 weeks Receives: Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate on the 16-item patient-reported Quick Inventory of Depressive Symptoms (QIDS-SR) at the week 8 endpoint as a function of biomarker score
The Quick Inventory of Depressive Symptomatology (QIDS-SR) is a 16 item self-report scale that measures depressive symptoms. The QIDS assesses the severity of all DSM-V criterion items required to diagnose a major depressive episode. It asks the patient to rate each of 16 items on a scale from 0 to 3. Additionally, it states the frequency and severity of symptoms that patients should consider while responding to items in the survey. Each item in the survey asks about depressive symptoms that the patient may have experienced in the past seven days.
Measured: 8 weeks
Secondary outcomes (2)
Percentage decrease in depressive symptoms on the QIDS-SR at the week 8 endpoint as a function of biomarker score
Quick Inventory of Depressive Symptoms (QIDS-SR)
Measured: 8 weeks
Absolute score decrease from baseline to the week 8 endpoint on the QIDS-SR as a function of biomarker score
Quick Inventory of Depressive Symptoms (QIDS-SR)
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 May 2020
- Study start15 Oct 2020 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Why it stopped: No participants enrolled
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.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alto Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Corey Keller, MD, PhD, Study director, Alto Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388189
- Sponsor's protocol ID
- LEAP-DB
- Acronym
- LEAP-DB
- Status last verified
- Oct 2020
- First submitted
- 11 May 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion (LEAP-DB): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Duloxetine Versus Bupropion in Adults With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04388189
- Acronym / sponsor ID
- LEAP-DB / LEAP-DB
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, EEG, Biomarker, Antidepressant, Duloxetine, Bupropion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alto NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 14 May 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.
The LEAP-DB study will be conducted to validate the utility of EEG biomarkers as an aid to antidepressant treatment selection in adults with MDD.
Detailed description
The LEAP-DB study is an 8-week, multicenter, randomized, blinded study to evaluate the performance of EEG-based biomarkers in predicting treatment outcome. Study participants will be randomized in a 1:1 ratio to receive either duloxetine or bupropion and followed for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: DuloxetineDuloxetine 60 mg daily for 8 weeks |
| Bupropion | Active comparator | Drug: BupropionBupropion 150-450 mg daily for 8 weeks |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged 22 or older at the time of informed consent.
- Diagnosis of Major Depressive Disorder (MDD) based on the Structured Clinical Interview for DSM-5 for depression.
- Moderate or severe depression on DSM-5 depression criteria items, as assessed by a score of 10 or more on the Patient Health Questionnaire (PHQ-9)
- Has not taken either study medications (duloxetine, bupropion) in the current episode
- Has not received electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or esketamine treatment in the current episode
Key exclusion criteria (9 listed)
- Diagnosis of bipolar disorder or a psychotic disorder based on the Structured Clinical Interview for DSM-5.
- Concurrent use of antipsychotics or mood stabilizers
- Use of hypnotics, anxiolytics or opiate pain medications greater than three days per week and unable to reduce use to three or fewer days per week on an as needed basis
- Pregnant or breastfeeding
- Severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks
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 |
|---|---|---|
| DuloxetineAlso: CymbaltaFDA approved antidepressant | Drug | Duloxetine |
| BupropionAlso: WellbutrinFDA approved antidepressant | Drug | Bupropion |
Primary outcome
Response rate on the 16-item patient-reported Quick Inventory of Depressive Symptoms (QIDS-SR) at the week 8 endpoint as a function of biomarker score
Time frame: 8 weeks
The Quick Inventory of Depressive Symptomatology (QIDS-SR) is a 16 item self-report scale that measures depressive symptoms. The QIDS assesses the severity of all DSM-V criterion items required to diagnose a major depressive episode. It asks the patient to rate each of 16 items on a scale from 0 to 3. Additionally, it states the frequency and severity of symptoms that patients should consider while responding to items in the survey. Each item in the survey asks about depressive symptoms that the patient may have experienced in the past seven days.
2 secondary outcomes
Percentage decrease in depressive symptoms on the QIDS-SR at the week 8 endpoint as a function of biomarker score
Time frame: 8 weeks
Absolute score decrease from baseline to the week 8 endpoint on the QIDS-SR as a function of biomarker score
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Corey Keller, MD, PhD study director
Alto Neuroscience
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine and Bupropion in people with Major Depressive Disorder, run by Alto Neuroscience.
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 9 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: withdrawn, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Response rate on the 16-item patient-reported Quick Inventory of Depressive Symptoms (QIDS-SR) at the week 8 endpoint as a function of biomarker score (time frame: 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 19 Oct 2020.