- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01916824
Effects of Treatment on Decision-making in Major Depression
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Emory Mood and Anxiety Disorders Program
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria for MDD Subjects:
- 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.
Inclusion Criteria for Healthy Control Subjects:
- 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
Exclusion Criteria for all subjects:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Participants with Major Depressive Disorder
Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
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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.
Ostatní jména:
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Žádný zásah: Healthy Controls
Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Money Earned
Časové okno: Baseline, Week 6
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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:
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Baseline, Week 6
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Symptomy chování
- Duševní poruchy
- Poruchy nálady
- Deprese
- Deprese
- Depresivní porucha, major
- Fyziologické účinky léků
- Adrenergní antagonisté
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Depresiva centrálního nervového systému
- Agenti periferního nervového systému
- Inhibitory enzymů
- Analgetika
- Agenti smyslového systému
- Uklidňující prostředky
- Psychotropní drogy
- Inhibitory vychytávání serotoninu
- Inhibitory vychytávání neurotransmiterů
- Membránové transportní modulátory
- Serotoninové látky
- Dopaminové látky
- Antagonisté serotoninového 5-HT2 receptoru
- Antagonisté serotoninu
- Prostředky proti úzkosti
- Inhibitory enzymu cytochromu P-450
- Antidepresiva, druhá generace
- Inhibitory zpětného vychytávání serotoninu a noradrenalinu
- Cytochrom P-450 Inhibitory CYP2D6
- Antagonisté serotoninového 5-HT3 receptoru
- Inhibitory vychytávání dopaminu
- Antagonisté histaminu H1
- Antagonisté histaminu
- Histaminové látky
- Adrenergní alfa-antagonisté
- Antagonisté adrenergních alfa-2 receptorů
- Sertralin
- Duloxetin hydrochlorid
- Citalopram
- Paroxetin
- Bupropion
- Desvenlafaxin sukcinát
- Venlafaxin hydrochlorid
- Mirtazapin
- Fluoxetin
- Antidepresiva
Další identifikační čísla studie
- IRB00066705
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