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Decision Making Study in Young and Middle-Aged Adults: Part II (DND)

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ClinicalTrials.gov Identifier: NCT03512171
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
David Zald, Vanderbilt University

Brief Summary:
Financial decisions are made during pre-retirement age that can influence financial well-being for the rest of an individual's life. This proposal aims to construct a more comprehensive model of the specific psychological and neural mechanisms that support financial decisions in young adulthood and late middle age. In Part 1 of this study (covered in Institutional Review Board (IRB) # 141812), middle-age and young adults complete basic cognitive, motivational, and decision making tasks and are studied with functional magnetic resonance imaging (fMRI) to determine the relation between neural circuit activation and individual and age-related differences in decision making. In part II of the study, aspects of dopamine functioning are studied using positron emission tomography (PET) scanning to determine whether individual differences in dopamine functions are related to the decision-making and fMRI measures collected in Part 1 of the study. Dopamine measures include baseline D2 receptor availability, amphetamine induced dopamine release and dopamine transporter (DAT) levels, which provides a more comprehensive evaluation of dopamine functions than in prior studies linking individual differences in dopamine to behavioral, cognitive or decision-making traits.

Condition or disease Intervention/treatment Phase
Healthy Adults Drug: Dextroamphetamine Drug: Placebo Diagnostic Test: [18F]Fallypride Diagnostic Test: [18F]-FE-PE2I Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All subjects receive the same diagnositc intervention, with counterbalanced order
Masking: Double (Participant, Investigator)
Masking Description: The participant and the research analyst running their session are both blind, however a PET tech is unmasked who monitors the participant for any adverse reactions.
Primary Purpose: Basic Science
Official Title: Dopaminergic Neuromodulation of Decision Making in Young and Middle-Aged Adults
Actual Study Start Date : March 31, 2016
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Amphetamine
One oral dose of dextroamphetamine (0.43 mg/kg) up to a maximum dose of 45mg. The dose is administered in 10mg and 2.5mg capsules prepared by the Vanderbilt Investigational Drug Services (IDS). Note: We are not testing the effect of dextro-amphetamine on a symptom. Rather it is part of the diagnostic intervention that is used to measure dopamine release assessed as the decline in [18F]fallypride binding relative to baseline.
Drug: Dextroamphetamine
One oral dose of dextroamphetamine (0.43mg/kg). The amphetamine is given in order to induce the release of their own dopamine for study with positron emission tomography (PET).
Other Name: d-amphetamine

Diagnostic Test: [18F]Fallypride
Radioligand for measuring dopamine D2 receptors with positron emission tomography (PET)
Other Name: [18F]Fallypride positron emission tomography

Placebo Comparator: Placebo
One oral placebo dose, with capsules prepared by the Vanderbilt Investigational Drug Services (IDS). This provides the baseline against which dopamine release is measured.
Drug: Placebo
One oral dose of placebo to estimate D2 receptor levels at baseline with PET imaging (necessary to calculate dopamine release in the amphetamine condition).

Diagnostic Test: [18F]Fallypride
Radioligand for measuring dopamine D2 receptors with positron emission tomography (PET)
Other Name: [18F]Fallypride positron emission tomography

Experimental: [18F]-FE-PE2I
[18F]-FE-PE2I is a radioligand for measuring dopamine transporters with positron emission tomography (PET). All participants complete this arm. The arm does not include administration of amphetamine or placebo.
Diagnostic Test: [18F]-FE-PE2I
Radioligand for measuring dopamine transporters with positron emission tomography (PET)
Other Name: [18F]-FE-PE2I positron emission tomography




Primary Outcome Measures :
  1. Dopamine D2 receptor availability (binding potential) [ Time Frame: 3- 6.5 hours ]
    D2 receptor availability is measured using positron emission tomography (PET) and the D2/D3 receptor radioligand [18F] fallypride. Contrast between receptor availability after amphetamine versus placebo forms the primary measure of dopamine release induced by amphetamine.


Secondary Outcome Measures :
  1. Quantification of Dopamine Transporter Levels [ Time Frame: 0 - 2 hours ]
    Dopamine transporter levels will be quantified with [18F]-FE-PE2I.

  2. Decision Making Task 1 [ Time Frame: 1-3 hours ]
    Effort Expenditure for Reward Task

  3. Decision Making Task 2 [ Time Frame: 1-3 hours ]
    Two-stage reward learning paradigm that follows the procedures by Daw et al. (2011)

  4. Cognitive Task 1 (processing speed) [ Time Frame: 1 - 2 hours ]
    WAIS-III Digit Symbol Coding and Symbol Search (aggregate score)

  5. Cognitive Task 2 (verbal fluency) [ Time Frame: 1 - 2 hours ]
    Controlled Oral Word Association Test

  6. Cognitive Task 3 [ Time Frame: 1 - 2 hours ]
    N-back task Working Memory Task (2-back & 3-back)

  7. Motor Task 1 [ Time Frame: 1 - 2 hours ]
    Finger Tapping Speed

  8. Change in Spontaneous Eye Blink Rate [ Time Frame: 1-2 hours ]
    Eye Blink Rate is measured with an eye tracker for 10 minutes, on or off amphetamine



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Total number of participants planned is 60 broken into 30 females and 30 males.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Medically, psychiatrically and neurologically healthy individuals between the 20-30 or 50-65 years of age. Subjects must be able to give informed consent, have an estimated intelligence quotient of greater than 80, and be a fluent English speaker.

Exclusion Criteria:

  1. Any condition which would interfere with or be a risk for MRI ( e.g. extreme obesity, claustrophobia, cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, metallic body inclusions or other metal implanted in the body, facial tattoos with iron pigment). Difficulty lying on one's back and claustrophobia are also exclusions.
  2. History of major psychiatric illness (including recurrent major depressive episodes or a depressive episode in the past 10 years, any anxiety disorders in the last 10 years, any history of bipolar disorder or psychotic disorder, a history of substance dependence (or substance abuse lasting more than 2 years), or any eating disorder in which symptoms persisted for more than two years
  3. Current tobacco use, alcohol intake greater than 8 ounces of whiskey or equivalent per week, use of any psychotropic medication for the past 6 months (other than occasional use of benzodiazepines for sleep), psychostimulants taken more than 5 times in the subject's life, current marijuana use 4 Neurological illness (other than headache or strictly peripheral nerve disturbance), or head trauma (including more than 2 concussions)

5) Significant untreated or unregulated major medical condition deemed likely to influence cognitive functioning, dopaminergic functioning or neuroimaging measures. Diabetes is an exclusion even if well-controlled.

6) History of Syncope during blood draws 7) Anemia or hematocrit < 34. 8) Participation in any research studies in the past year that involved radiation, or exposure to radiation on a routine basis due to their occupation.

9) High blood pressure (Systolic B.P. > 150 in participants under the age of 61, or > 145 in subjects > 61 years of age). Diagnosis of labile hypertension. Abnormal EKG indicating potential cardiac risk under conditions of increased blood pressure.

10) Current pregnancy or lactation or plans to become pregnant during the study timeframe.

As part of the screening process in protocol # 141812, participants are initially screened with a brief telephone interview to determine if they meet medical, psychiatric and neurological criteria (all information screened is included in attached screening form). Participants are not consented until after completion of the brief health interview (a waiver of consent is in place in order to perform the initial telephone screening). After being consented participants complete a medical history and physical exam with one of the study MD's. They also complete a psychiatric interview (SCID-IV or V) with one of the trained psychology research assistants or Dr. Zald, and finally an EKG is completed. Participants are not enrolled in the present phase of the study until all exclusion criteria are assessed and they are withdrawn from the study if new information arises that would alter the conclusion regarding any of the inclusion/exclusion criteria after enrollment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512171


Locations
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United States, Tennessee
Zald Affective Neuroscience Lab- Vanderbilt University
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
Duke University
Investigators
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Principal Investigator: David Zald, Zald Vanderbilt University
  Study Documents (Full-Text)

Documents provided by David Zald, Vanderbilt University:

Publications:
Charles ST, Carstensen LL. Emotion regulation and aging. Gross JJ, editor. Handbook of Emotion Regulation. New York: Guilford Press; 2007. p. 307-20.
Samanez-Larkin GR, Carstensen LL. Socioemotional Functioning and the Aging Brain. Decety J, Cacioppo JT, editors. The Handbook of Social Neuroscience. Oxford University Press; 2011. p. 507-21.
Rubin DC. Frontal-Striatal Circuits in Cognitive Aging: Evidence for Caudate Involvement. Aging, Neuropsychology, and Cognition. 1999;6(4):241-59.
Salthouse TA. What and When of Cognitive Aging. Current Directions in Psychological Science. 2004;13(4):140-4.
Raz N. The Aging Brain Observed in Vivo: Differential Changes and Their Modifiers. Cabeza R, Nyberg L, Park D, editors. Cognitive neuroscience of aging: Linking cognitive and cerebral aging. Oxford University Press, New York, NY, US; 2005. p. 19-57.
Kessler RM, Mason NS, Jones C, Ansari MS, Manning RF, Price RR. [18F]N-allyl-5-fluoropropylepidepride (fallypride): radiation dosimetry, quantification of striatal and extrastriatal dopamine receptors in man. NeuroImage. 2000Aug.26;11:S32.
Stroop JE. Studies of interference in serial verbal reactions. J Exp Psychol Gen. 1935;:18643-62.
Wechsler D. Wechsler Memory Scale, 3rd edition. San Antonio, TX: Psychological Corporation; 1997.
Wechsler D. Wechsler Adult Intelligence Scale, 3rd Edition. San Antonio, TX: Psychological Corporation; 1997.
Rogers R, Monsell S. Costs of a predictible switch between simple cognitive tasks. Journal of experimental psychology: General. 1995;124(2):207-31.
Park DC, Schwarz N, editors. Cognitive aging: A primer. Psychology Press, New York, NY, US; 2000.
Carver CS, White TL. Behavioral Inhibition, Behavioral Activation, and Affective Responses to Impending Reward and Punishment: The BIS/BAS Scales. Journal of Personality and Social Psychology. 1994;67(2):319-33.
Costa PT, McCrae RR. Normal personality assessment in clinical practice: The NEO Personality Inventory. Psychological Assessment. 1992Mar.;4(1):5-13.
Carstensen LL, Lang FR. Future Time Perspective Scale. 1995.

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Responsible Party: David Zald, Cornelius Vanderbilt Professor of Psychology and Professor of Psychiatry, Vanderbilt University
ClinicalTrials.gov Identifier: NCT03512171     History of Changes
Other Study ID Numbers: 151088
AG043458 ( Other Grant/Funding Number: MINH )
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dopamine
Amphetamine
Dextroamphetamine
Fallypride
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Stimulants
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Dopamine D2 Receptor Antagonists
Dopamine Antagonists