DepressionPhase 4PRECISE-DNCT03993457
Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression
A Phase 4 study testing Escitalopram and Bupropion in people with Depression, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
PRECISE-D is a single site, randomized, open label 8-week clinical trial that will enroll 70 participants to evaluate if the level of inflammation in our body can predict how we will respond to antidepressants. C-reactive protein (CRP) is a substance in the body that is associated with inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram and Bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2019to 25 Mar 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women and men ages 18-65
- Current diagnosis of Major Depressive Disorder
- Able to read, speak, and understand English
Who cannot join
- Antidepressant use within the last 8 weeks
- Active infection or uncontrolled autoimmune disease
- Currently on oral corticosteroids or active immune suppressive therapy (methotrexate, cyclosporine, anti-cytokines medications, etc).
- Current diagnosis of uncontrolled HIV, hepatitis C or significant immunodeficiency
- Alcohol or substance use disorder
- Positive urine drug test for illicit substances or substances used out of the context of prescription
Show all 16Show fewer
- Cognitively unable to give informed consent
- Pregnant or breastfeeding women, women of childbearing potential who are not using an accepted means of birth control, or women with a positive urine pregnancy test
- History of seizure disorder
- Previous significant adverse reaction to escitalopram or bupropion
- History of non-response to adequate doses of escitalopram or bupropion XL
- Current use of concomitant psychotropic agents (anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, folate, l-methylfolate, s-adenosyl methionine, lithium) not on the same dose for at least four weeks prior to study entry or who do not agree to continue at the same dose during the acute phase of the study.
- Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder
- Current anorexia nervosa or bulimia nervosa
- Suicidal ideation of the degree that, in the opinion of the evaluating clinician, participation in the study would place them at significantly increased risk of suicide
- Unstable medical issues of such degree that, in the opinion of the evaluating clinician, participation in the study would place them at significant risk of a serious adverse event
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
PRECISE-D is a single site, randomized, open label 8-week clinical trial that will enroll 70 participants to evaluate if the level of inflammation in our body can predict how we will respond to antidepressants. C-reactive protein (CRP) is a substance in the body that is associated with inflammation. Previous research has suggested that people with high CRP (i.e., high inflammation levels) tend to have greater improvement of depressive symptoms with an antidepressant called bupropion, while individuals with low CRP (i.e., low inflammation levels) appear to have more benefit from selective serotonin reuptake inhibitors antidepressants (SSRI), such as escitalopram. However, it is not completely clear if CRP can predict your response to these two antidepressants.
Participants will undergo a screening visit that includes a physical exam, overall health evaluation, assessment of mental health history, and a toxicology and pregnancy test. Once screening is complete, participants will be randomized to one of two groups that will determine whether their CRP levels will be used to select which antidepressant they will receive. Participants will then complete 4 follow up visits at weeks 2, 4, 6, and 8. A follow-up phone call from the study team will occur at week 12.
Read the detailed description
PRECISE-D is a single site, randomized, open label 8-week clinical trial that will enroll 70 participants. Participants will be asked to attend approximately 5 visits with the researchers or study staff.
The screening process will take approximately 2 hours, and will include a physical examination, toxicology and pregnancy test, as well as the completion of assessments. We will ask participants a series of questions regarding their general health, mental health history, and any medications they are currently taking. Additionally, some self-report questionnaires will be used as part of this process. The results of the screening exams, tests, and/or procedures will be reviewed to determine whether a participant will be allowed to continue in the study. In the event that there are questions about a participant's eligibility or screening procedures are remaining, the screening visit may be conducted over 2 visits.
Once eligibility is determined, the baseline visit (Week 0) will be completed. This visit will last approximately 1 hour and 15 minutes and will include the following:
- Bloodwork: We will obtain levels of CRP and other inflammatory substances. We will also examine electrolytes, kidney function, thyroid function, lipid panel, blood cell count, and other tests of general health.
- Self-Report Questionnaires: Participants will complete 8 questionnaires. These include questions about mental health and mood. The questionnaires range from 5 to 20+ items.
- Cognitive tests: We will examine the participant's attention, memory, and cognition using a series of computerized assessments.
Participants will be assigned to a study group based on their CRP level: CRP less than 1 (low CRP), or CRP greater than or equal to 1 (high CRP). Within this group assignment, participants will then be randomized, or assigned by chance (like flipping a coin), to one of 2 study groups:
- CRP consistent antidepressant selection (medication will be prescribed based on participant's CRP level).
If CRP less than 1, participant will be prescribed escitalopram. If CRP greater than or equal to 1, participant will be prescribed bupropion XL.
- CRP inconsistent antidepressant selection (medication will be prescribed in contradiction to participant's CRP level) If CRP less than 1, participant will be prescribed bupropion XL. If CRP greater than or equal to 1, participant will be prescribed escitalopram.
In each group participants will receive either escitalopram or bupropion XL.
- 1 tablet of 150 mg of bupropion-XL per day (initial dose). The dose will be increased to 300mg per day after the first week, and may be increased up to 450 mg/per day if deemed necessary by the clinician.
- 1 tablet of 5 mg of escitalopram per day (initial dose). The dose will be increased to 10 mg per day after the first week, followed by an additional increase to 20 mg/day if deemed necessary by clinician.
Participants and study doctors will know which medication is being used, but not which group the participant is in; that is, participants and study doctors will not know the participant's CRP levels nor whether the medication assignment is consistent with CRP levels. The dose of the medication may be adjusted up or down during the study to improve effects of the medication or reduce possible side effects. Dose changes will be made based on how the participant is feeling and any side effects.
Participants will then complete a clinical visit at Week 2, 4, and 6. These visits will last approximately 1 hour and 15 minutes, and will include the following:
- Clinical Evaluation: a psychiatrist will check the participant's vital signs and assess their overall wellbeing. Symptom changes, side effects, and adherence to treatment will be evaluated. Medication dosage adjustments will be made as necessary.
- Self-Report Questionnaires
The final clinical visit will occur at week 8. This visit will be the last in person visit and will last approximately 1 hour and 45 minutes. The following will be completed
- Clinical Evaluation
- Self-Report Questionnaires
- Cognitive tests
- Bloodwork
- Pregnancy test (if you are a female able to become pregnant)
After study completion, participants who wish to remain on treatment will be given a four week supply of study drug while they transition care.
Additionally, a remote follow up assessment will be done at Week 12. Participants will be contacted via phone to complete a series of questionnaires. Additionally, they will receive a series of self reports via email. Paper forms will be also available at the Center for Depression Research and Clinical Care if the participant prefers to answer them on paper or don't have access to an email.
The self-report questionnaires, study evaluations, and assessment of CRP levels and additional inflammatory substances in this study are designed for research, not for medical purposes. Even though the researchers are not specifically looking at blood to find a medical problem, participants will be notified if any abnormal results are identified.
Participants will also have the option to participate in a Finger Prick Blood CRP substudy that will compare CRP results based on the blood source: venous blood obtained via venipuncture and capillary blood obtained via finger prick. A few drops of capillary blood will be collected via finger prick once during the study at week 0 (screening/baseline). We will compare the finger prick results to the results obtained from venipuncture at the same visit.
- Conditions
- Depression
- Being tested
- Escitalopram, Bupropion
- Keywords
- depression, mental health, mood disorders, major depressive episode, major depressive disorder, antidepressants, escitalopram, bupropion, depression treatment
- Medical subject headings
- Depression, Psychological Well-Being, Mood Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
BupropionDrug
Also called Wellbutrin XL
Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
| Study group | Role | What they receive |
|---|---|---|
| CRP<1, CRP consistent antidepressant selection | Other | Participants with CRP<1 will be prescribed escitalopram Receives: Drug: Escitalopram |
| CRP> or equal to 1, CRP consistent antidepressant selection | Other | Participants with CRP> or equal to 1 will be prescribed bupropion XL Receives: Drug: Bupropion |
| CRP<1, CRP inconsistent antidepressant selection | Other | Participants with CRP< 1 will be prescribed bupropion XL Receives: Drug: Bupropion |
| CRP> or equal to 1, CRP inconsistent antidepressant selection | Other | Participants with CRP> or equal to 1 will be prescribed escitalopram Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Remission Rates in Patients With MDD.
The primary study endpoint will be remission rates based on the 16-items Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR), which will be extracted from the 30-item Inventory of Depressive Symptomatology (IDS-SR). The QIDS-SR score ranges from 0-27. A score of 5 or less represents remission.
Measured: 1 year
Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Improving Social and Occupational Functioning.
Improvement in social and occupational functioning will be measured with the 5-item self-administered Work and Social Adjustment Scale (WSAS). The WSAS total score ranges from 0-40. Lower scores are better.
Measured: 12 weeks
Adverse Antidepressant Treatment Effects on CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection
Side effects will be assessed using the 3-item self-administered Frequency, Intensity, and Burden of Side Effects (FIBSER). Each item is scored on a scale from 0-6. Items 1 and 2 (Frequency \& Intensity respectively) are to provide information to the clinician, but they are not used in the scoring.The score that is used comes only from Item 3 - Burden. Lower scores represents lower burden.
Measured: 1 year
Secondary outcomes (1)
Optional Sub-study. Validity and Reliability of Capillary Blood CRP Measurement
Capillary blood CRP levels will be compared with those obtained using venous blood obtained via venipuncture. Outcome will be number of participants whose capillary blood CRP levels and venous blood CRPT levels match in terms of <1 vs. >=1.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start23 Jul 2019
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Why it stopped: terminated during COVID due to inability to see participants in person.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies 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
- Model description
- Participants will be assigned to one of two groups based on their CRP levels: * CRP less than 1 * CRP greater than or equal to 1 Participants within both groups will then be randomized to one of 2 groups, which is stratified by a CRP group: * CRP consistent antidepressant selection (medication will be prescribed based on CRP level) * CRP inconsistent antidepressant selection (medication will be prescribed in contradiction to CRP level)
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar H Trivedi, MD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993457
- Sponsor's protocol ID
- STU-2019-0623
- Acronym
- PRECISE-D
- Status last verified
- Mar 2023
- First submitted
- 13 Jun 2019
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression
- ClinicalTrials.gov ID
- NCT03993457
- Acronym / sponsor ID
- PRECISE-D / STU-2019-0623
- Conditions
- Depression
- Keywords
- depression, mental health, mood disorders, major depressive episode, major depressive disorder, antidepressants, escitalopram, bupropion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated during COVID due to inability to see participants in person.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PRECISE-D is a single site, randomized, open label 8-week clinical trial that will enroll 70 participants to evaluate if the level of inflammation in our body can predict how we will respond to antidepressants. C-reactive protein (CRP) is a substance in the body that is associated with inflammation. Previous research has suggested that people with high CRP (i.e., high inflammation levels) tend to have greater improvement of depressive symptoms with an antidepressant called bupropion, while individuals with low CRP (i.e., low inflammation levels) appear to have more benefit from selective serotonin reuptake inhibitors antidepressants (SSRI), such as escitalopram. However, it is not completely clear if CRP can predict your response to these two antidepressants.
Participants will undergo a screening visit that includes a physical exam, overall health evaluation, assessment of mental health history, and a toxicology and pregnancy test. Once screening is complete, participants will be randomized to one of two groups that will determine whether their CRP levels will be used to select which antidepressant they will receive. Participants will then complete 4 follow up visits at weeks 2, 4, 6, and 8. A follow-up phone call from the study team will occur at week 12.
Detailed description
PRECISE-D is a single site, randomized, open label 8-week clinical trial that will enroll 70 participants. Participants will be asked to attend approximately 5 visits with the researchers or study staff.
The screening process will take approximately 2 hours, and will include a physical examination, toxicology and pregnancy test, as well as the completion of assessments. We will ask participants a series of questions regarding their general health, mental health history, and any medications they are currently taking. Additionally, some self-report questionnaires will be used as part of this process. The results of the screening exams, tests, and/or procedures will be reviewed to determine whether a participant will be allowed to continue in the study. In the event that there are questions about a participant's eligibility or screening procedures are remaining, the screening visit may be conducted over 2 visits.
Once eligibility is determined, the baseline visit (Week 0) will be completed. This visit will last approximately 1 hour and 15 minutes and will include the following:
- Bloodwork: We will obtain levels of CRP and other inflammatory substances. We will also examine electrolytes, kidney function, thyroid function, lipid panel, blood cell count, and other tests of general health.
- Self-Report Questionnaires: Participants will complete 8 questionnaires. These include questions about mental health and mood. The questionnaires range from 5 to 20+ items.
- Cognitive tests: We will examine the participant's attention, memory, and cognition using a series of computerized assessments.
Participants will be assigned to a study group based on their CRP level: CRP less than 1 (low CRP), or CRP greater than or equal to 1 (high CRP). Within this group assignment, participants will then be randomized, or assigned by chance (like flipping a coin), to one of 2 study groups:
- CRP consistent antidepressant selection (medication will be prescribed based on participant's CRP level).
If CRP less than 1, participant will be prescribed escitalopram. If CRP greater than or equal to 1, participant will be prescribed bupropion XL.
- CRP inconsistent antidepressant selection (medication will be prescribed in contradiction to participant's CRP level) If CRP less than 1, participant will be prescribed bupropion XL. If CRP greater than or equal to 1, participant will be prescribed escitalopram.
In each group participants will receive either escitalopram or bupropion XL.
- 1 tablet of 150 mg of bupropion-XL per day (initial dose). The dose will be increased to 300mg per day after the first week, and may be increased up to 450 mg/per day if deemed necessary by the clinician.
- 1 tablet of 5 mg of escitalopram per day (initial dose). The dose will be increased to 10 mg per day after the first week, followed by an additional increase to 20 mg/day if deemed necessary by clinician.
Participants and study doctors will know which medication is being used, but not which group the participant is in; that is, participants and study doctors will not know the participant's CRP levels nor whether the medication assignment is consistent with CRP levels. The dose of the medication may be adjusted up or down during the study to improve effects of the medication or reduce possible side effects. Dose changes will be made based on how the participant is feeling and any side effects.
Participants will then complete a clinical visit at Week 2, 4, and 6. These visits will last approximately 1 hour and 15 minutes, and will include the following:
- Clinical Evaluation: a psychiatrist will check the participant's vital signs and assess their overall wellbeing. Symptom changes, side effects, and adherence to treatment will be evaluated. Medication dosage adjustments will be made as necessary.
- Self-Report Questionnaires
The final clinical visit will occur at week 8. This visit will be the last in person visit and will last approximately 1 hour and 45 minutes. The following will be completed
- Clinical Evaluation
- Self-Report Questionnaires
- Cognitive tests
- Bloodwork
- Pregnancy test (if you are a female able to become pregnant)
After study completion, participants who wish to remain on treatment will be given a four week supply of study drug while they transition care.
Additionally, a remote follow up assessment will be done at Week 12. Participants will be contacted via phone to complete a series of questionnaires. Additionally, they will receive a series of self reports via email. Paper forms will be also available at the Center for Depression Research and Clinical Care if the participant prefers to answer them on paper or don't have access to an email.
The self-report questionnaires, study evaluations, and assessment of CRP levels and additional inflammatory substances in this study are designed for research, not for medical purposes. Even though the researchers are not specifically looking at blood to find a medical problem, participants will be notified if any abnormal results are identified.
Participants will also have the option to participate in a Finger Prick Blood CRP substudy that will compare CRP results based on the blood source: venous blood obtained via venipuncture and capillary blood obtained via finger prick. A few drops of capillary blood will be collected via finger prick once during the study at week 0 (screening/baseline). We will compare the finger prick results to the results obtained from venipuncture at the same visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be assigned to one of two groups based on their CRP levels: * CRP less than 1 * CRP greater than or equal to 1 Participants within both groups will then be randomized to one of 2 groups, which is stratified by a CRP group: * CRP consistent antidepressant selection (medication will be prescribed based on CRP level) * CRP inconsistent antidepressant selection (medication will be prescribed in contradiction to CRP level)
| Arm | Type | Receives |
|---|---|---|
| CRP<1, CRP consistent antidepressant selection | Other | Drug: EscitalopramParticipants with CRP<1 will be prescribed escitalopram |
| CRP> or equal to 1, CRP consistent antidepressant selection | Other | Drug: BupropionParticipants with CRP> or equal to 1 will be prescribed bupropion XL |
| CRP<1, CRP inconsistent antidepressant selection | Other | Drug: BupropionParticipants with CRP< 1 will be prescribed bupropion XL |
| CRP> or equal to 1, CRP inconsistent antidepressant selection | Other | Drug: EscitalopramParticipants with CRP> or equal to 1 will be prescribed escitalopram |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women and men ages 18-65
- Current diagnosis of Major Depressive Disorder
- Able to read, speak, and understand English
Key exclusion criteria (16 listed)
- Antidepressant use within the last 8 weeks
- Active infection or uncontrolled autoimmune disease
- Currently on oral corticosteroids or active immune suppressive therapy (methotrexate, cyclosporine, anti-cytokines medications, etc).
- Current diagnosis of uncontrolled HIV, hepatitis C or significant immunodeficiency
- Alcohol or substance use disorder
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 |
|---|---|---|
| EscitalopramAlso: LexaproEscitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study. | Drug | CRP<1, CRP consistent antidepressant selection, CRP> or equal to 1, CRP inconsistent antidepressant selection |
| BupropionAlso: Wellbutrin XLBupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study. | Drug | CRP<1, CRP inconsistent antidepressant selection, CRP> or equal to 1, CRP consistent antidepressant selection |
Primary outcome
Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Remission Rates in Patients With MDD.
Time frame: 1 year
The primary study endpoint will be remission rates based on the 16-items Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR), which will be extracted from the 30-item Inventory of Depressive Symptomatology (IDS-SR). The QIDS-SR score ranges from 0-27. A score of 5 or less represents remission.
Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Improving Social and Occupational Functioning.
Time frame: 12 weeks
Improvement in social and occupational functioning will be measured with the 5-item self-administered Work and Social Adjustment Scale (WSAS). The WSAS total score ranges from 0-40. Lower scores are better.
Adverse Antidepressant Treatment Effects on CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection
Time frame: 1 year
Side effects will be assessed using the 3-item self-administered Frequency, Intensity, and Burden of Side Effects (FIBSER). Each item is scored on a scale from 0-6. Items 1 and 2 (Frequency \& Intensity respectively) are to provide information to the clinician, but they are not used in the scoring.The score that is used comes only from Item 3 - Burden. Lower scores represents lower burden.
1 secondary outcome
Optional Sub-study. Validity and Reliability of Capillary Blood CRP Measurement
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Madhukar H Trivedi, MD principal investigator
UTSW
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 Escitalopram and Bupropion in people with Depression, run by University of Texas Southwestern Medical Center 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 3 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 18 Apr 2023. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Remission Rates in Patients With MDD. (time frame: 1 year). The study lists 3 primary outcomes in all. 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 18 Apr 2023; AzTrials last refreshed its copy on 30 Oct 2026.