Major Depressive DisorderPhase 4NCT01916824
Effects of Treatment on Decision-making in Major Depression
A Phase 4 study testing Any FDA Approved Antidepressant in people with Major Depressive Disorder and Healthy Controls, run by Emory University at 1 site in United States.
Trial summary
In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Healthy Controls
- What is being tested?
- Any FDA Approved Antidepressant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 18-65
- Primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) Diagnosis of Major Depressive Disorder.
- Has a 17-item Hamilton depression rating scale (HDRS-17) score >=16.
- Ability to visually read and understand English language
- Not currently taking an antidepressant.
- Women of reproductive potential must be willing to take a medically approved form of birth control throughout the duration of the study.
Show all 12Show fewer
- Male or female, age 18-65
- No current DSM-IV TR diagnosis of a mental illness.
- No lifetime history of Major Depressive Disorder or Dysthymia.
- Has a 17-item Hamilton depression rating scale (HDRS-17) score ≤7.
- Ability to visually read and understand English language
- Not currently taking any psychoactive medication
Who cannot join
- Has met criteria at any time during their life for bipolar disorder, a primary psychotic disorder (e.g. schizophrenia), or dementia.
- Meet criteria for substance abuse or dependence within three months of the screening visit.
- Presents with a clinically significant suicide risk, as assessed by a study physician.
- Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
- Women who are currently pregnant or lactating, or plan to become pregnant during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Mood and Anxiety Disorders Program
Atlanta, Georgia, 30322
About this study
In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. There will be three visits for depressed patients and two for healthy controls (the first and third visits). The first visit will involve interviews and questionnaires to assess the participant's level of depression, medical history and quality of life. Participants will then complete the decision-making tasks, and will earn between $5-40 based on their choices, in order to make the decisions on the computer tasks financially meaningful. At the completion of this visit, depressed patients will be prescribed an FDA-approved antidepressant, chosen in consultation with the treating psychiatrist. Patients will be responsible for paying for the prescription themselves. After two weeks on the medication, the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After six weeks on the medicine, patients and healthy controls will return to repeat the questionnaires and the computer based decision-making tasks, and will again earn between $5-40 based on their performance.
Read the detailed description
During episodes of depression patients with major depressive disorder (MDD) may make sub-optimal decisions based on exaggerated negative beliefs about themselves, the future, or the world around them. These disruptions in decision-making contribute adversely to quality of life, in both work and personal realms. Although effective treatments for depression are available, very little work has explored the effects of treatment on how people make decisions. The specific aspects of decision-making that differ between depressed and health control individuals are unknown, and whether any changes in these decision-making features occur as a result of improvement from depression, or whether medication treatment itself can lead to changes in decision-making, even in the absence of clinical improvement.
In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. There will be three visits for depressed patients and two for healthy controls (the first and third visits). The first visit will involve interviews and questionnaires to assess the participant's level of depression, medical history and quality of life. Participants will then complete the decision-making tasks, and will earn between $5-40 based on their choices, in order to make the decisions on the computer tasks financially meaningful. At the completion of this visit, depressed patients will be prescribed an FDA-approved antidepressant, chosen in consultation with the treating psychiatrist. Patients will be responsible for paying for the prescription themselves. After two weeks on the medication, the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After six weeks on the medicine, patients and healthy controls will return to repeat the questionnaires and the computer based decision-making tasks, and will again earn between $5-40 based on their performance.
The overall goal of this study will be to identify whether decision-making characteristics in people with major depression is affected by treatment, and whether depressed patients make decisions differently from healthy controls. A total of 4 decision-making tasks and one control task will be administered via computer to eligible subjects. The specific tasks are:
- Risk Task - This task assesses tolerance of risk by having participants decide whether they wish to accept a specific dollar payout, or to play a lottery with an uncertain payout.
- Balloon Analogue Risk Task - The participant is presented with a balloon and offered the chance to earn money by pumping the balloon up by clicking a button. Each click causes the balloon to incrementally inflate and money to be added to a counter up until some threshold, at which point the balloon is over inflated and explodes. Thus, each pump confers greater risk but also greater potential reward. If the participant chooses to cash-out prior to the balloon exploding then they collect the money earned for that trial, but if balloon explodes earnings for that trial are lost. Participants are not informed about the balloons breakpoints; the absence of this information allows for testing both participants' initial responses to the task and changes in responding as they gain experience with the task contingencies.
- Temporal Discounting Task - Participants are initially asked to choose between taking an immediate reward now or a larger reward at some time in the future. Decisions for seven time points over a 10-year time frame are proposed. The task is then repeated using choices between immediate and delayed losses, based on the same seven time points. This task assesses the manner in which subjects value immediate outcomes compared to long-term consequences.
- Ultimatum Game - The ultimatum game (UG) is a well-established game-theoretical paradigm commonly employed in behavioral economics to measure emotional reactions to unfair offers. In the UG, two subjects sequentially exchange real monetary amounts. Specifically, a proposer is provided with a sum of money by the experimenter ($10), and asked to share this amount of money with another player, the responder. The responder then decides whether to accept or reject the offer made by the proposer. If the responder accepts the offer, both players receive the respective amounts from the proposer's offer. If she rejects the offer made by the proposer, both players receive nothing ($0). This is best illustrated via the following two potential scenarios: 1. the proposer offers a fair split of $5 for himself and $5 for the responder. This is an offer that is typically accepted by a great majority of responders. 2. The proposer offers a split of $9 for himself and $1 for the responder. Such offers are commonly rejected by the majority of responders, despite incurring a financial loss of $1.
- Continuous Performance Task - This task involves identifying patterns of numbers briefly displayed on a computer screen. This task will serve as a control variable for attention in analyzing the results of the decision-making tasks.
- Conditions
- Major Depressive Disorder, Healthy Controls
- Being tested
- Any FDA Approved Antidepressant
- Keywords
- depression, melancholia, treatment
- 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.
Any FDA Approved AntidepressantDrug
Also called Sertraline, Zoloft, Citalopram, Celexa, Escitalopram, Lexapro, Paroxetine, Paxil
Any FDA-approved antidepressant prescribed within standard dose range to treat Major Depressive Disorder will be taken for 6 weeks. Psychiatric follow-up will be performed during the study participation. At the end of the study, these participants will receive assistance in transitioning their care to another provider, depending on their individual circumstances.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Major Depressive Disorder | Experimental | Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks Receives: Drug: Any FDA Approved Antidepressant |
| Healthy Controls | No intervention | Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Money Earned
Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical "points" that do not have meaning in the real world. Greater earnings indicate better financial decision-making.
The specific tasks were:
- risk task
- balloon analogue risk task
- temporal discounting task
- ultimatum game
- continuous performance task
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionDec 2015
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 Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boadie W. Dunlop, Emory University
- Investigators
- Boadie W Dunlop, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916824
- Sponsor's protocol ID
- IRB00066705
- Status last verified
- Oct 2017
- First submitted
- 3 Aug 2013
- Last updated
- 21 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treatment on Decision-making in Major Depression
- ClinicalTrials.gov ID
- NCT01916824
- Acronym / sponsor ID
- IRB00066705
- Conditions
- Major Depressive Disorder, Healthy Controls
- Keywords
- depression, melancholia, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Posted 20 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. There will be three visits for depressed patients and two for healthy controls (the first and third visits). The first visit will involve interviews and questionnaires to assess the participant's level of depression, medical history and quality of life. Participants will then complete the decision-making tasks, and will earn between $5-40 based on their choices, in order to make the decisions on the computer tasks financially meaningful. At the completion of this visit, depressed patients will be prescribed an FDA-approved antidepressant, chosen in consultation with the treating psychiatrist. Patients will be responsible for paying for the prescription themselves. After two weeks on the medication, the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After six weeks on the medicine, patients and healthy controls will return to repeat the questionnaires and the computer based decision-making tasks, and will again earn between $5-40 based on their performance.
Detailed description
During episodes of depression patients with major depressive disorder (MDD) may make sub-optimal decisions based on exaggerated negative beliefs about themselves, the future, or the world around them. These disruptions in decision-making contribute adversely to quality of life, in both work and personal realms. Although effective treatments for depression are available, very little work has explored the effects of treatment on how people make decisions. The specific aspects of decision-making that differ between depressed and health control individuals are unknown, and whether any changes in these decision-making features occur as a result of improvement from depression, or whether medication treatment itself can lead to changes in decision-making, even in the absence of clinical improvement.
In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. There will be three visits for depressed patients and two for healthy controls (the first and third visits). The first visit will involve interviews and questionnaires to assess the participant's level of depression, medical history and quality of life. Participants will then complete the decision-making tasks, and will earn between $5-40 based on their choices, in order to make the decisions on the computer tasks financially meaningful. At the completion of this visit, depressed patients will be prescribed an FDA-approved antidepressant, chosen in consultation with the treating psychiatrist. Patients will be responsible for paying for the prescription themselves. After two weeks on the medication, the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After six weeks on the medicine, patients and healthy controls will return to repeat the questionnaires and the computer based decision-making tasks, and will again earn between $5-40 based on their performance.
The overall goal of this study will be to identify whether decision-making characteristics in people with major depression is affected by treatment, and whether depressed patients make decisions differently from healthy controls. A total of 4 decision-making tasks and one control task will be administered via computer to eligible subjects. The specific tasks are:
- Risk Task - This task assesses tolerance of risk by having participants decide whether they wish to accept a specific dollar payout, or to play a lottery with an uncertain payout.
- Balloon Analogue Risk Task - The participant is presented with a balloon and offered the chance to earn money by pumping the balloon up by clicking a button. Each click causes the balloon to incrementally inflate and money to be added to a counter up until some threshold, at which point the balloon is over inflated and explodes. Thus, each pump confers greater risk but also greater potential reward. If the participant chooses to cash-out prior to the balloon exploding then they collect the money earned for that trial, but if balloon explodes earnings for that trial are lost. Participants are not informed about the balloons breakpoints; the absence of this information allows for testing both participants' initial responses to the task and changes in responding as they gain experience with the task contingencies.
- Temporal Discounting Task - Participants are initially asked to choose between taking an immediate reward now or a larger reward at some time in the future. Decisions for seven time points over a 10-year time frame are proposed. The task is then repeated using choices between immediate and delayed losses, based on the same seven time points. This task assesses the manner in which subjects value immediate outcomes compared to long-term consequences.
- Ultimatum Game - The ultimatum game (UG) is a well-established game-theoretical paradigm commonly employed in behavioral economics to measure emotional reactions to unfair offers. In the UG, two subjects sequentially exchange real monetary amounts. Specifically, a proposer is provided with a sum of money by the experimenter ($10), and asked to share this amount of money with another player, the responder. The responder then decides whether to accept or reject the offer made by the proposer. If the responder accepts the offer, both players receive the respective amounts from the proposer's offer. If she rejects the offer made by the proposer, both players receive nothing ($0). This is best illustrated via the following two potential scenarios: 1. the proposer offers a fair split of $5 for himself and $5 for the responder. This is an offer that is typically accepted by a great majority of responders. 2. The proposer offers a split of $9 for himself and $1 for the responder. Such offers are commonly rejected by the majority of responders, despite incurring a financial loss of $1.
- Continuous Performance Task - This task involves identifying patterns of numbers briefly displayed on a computer screen. This task will serve as a control variable for attention in analyzing the results of the decision-making tasks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Major Depressive Disorder | Experimental | Drug: Any FDA Approved AntidepressantPersons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks |
| Healthy Controls | No intervention | –Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female, age 18-65
- Primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) Diagnosis of Major Depressive Disorder.
- Has a 17-item Hamilton depression rating scale (HDRS-17) score >=16.
- Ability to visually read and understand English language
- Not currently taking an antidepressant.
Key exclusion criteria (5 listed)
- Has met criteria at any time during their life for bipolar disorder, a primary psychotic disorder (e.g. schizophrenia), or dementia.
- Meet criteria for substance abuse or dependence within three months of the screening visit.
- Presents with a clinically significant suicide risk, as assessed by a study physician.
- Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
- Women who are currently pregnant or lactating, or plan to become pregnant during 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 |
|---|---|---|
| Any FDA Approved AntidepressantAlso: Sertraline, Zoloft, Citalopram, Celexa, Escitalopram, Lexapro, Paroxetine, PaxilAny FDA-approved antidepressant prescribed within standard dose range to treat Major Depressive Disorder will be taken for 6 weeks. Psychiatric follow-up will be performed during the study participation. At the end of the study, these participants will receive assistance in transitioning their care to another provider, depending on their individual circumstances. | Drug | Participants with Major Depressive Disorder |
Primary outcome
Money Earned
Time frame: Baseline, Week 6
Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical "points" that do not have meaning in the real world. Greater earnings indicate better financial decision-making. The specific tasks were: 1. risk task 2. balloon analogue risk task 3. temporal discounting task 4. ultimatum game 5. continuous performance task
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Emory Mood and Anxiety Disorders Program home pageLink provided by the sponsor.
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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.
Boadie W Dunlop, MD principal investigator
Emory University
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 Any FDA Approved Antidepressant in people with Major Depressive Disorder and Healthy Controls, run by Emory University 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 12 inclusion and 5 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 21 Nov 2017. 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 20 Oct 2017). 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?
Money Earned (time frame: Baseline, Week 6). 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 21 Nov 2017.