NCT03181841|CompletedPhase 1
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Sponsor study identifier
interventional
120
1 country
1
Study Start
May 8, 2017
Actual (reported)Primary Completion
December 20, 2017
Actual (reported)Study Completion
December 20, 2017
Actual (reported)Numerous psychiatric and neurodegenerative diseases like schizophrenia, dependency on drugs of abuse, depression and Parkinson's disease are related to motivational and cognitive deficits in value-based decision making, which frequently persist even after a successful pharmacological treatment. According to current neurobiologic models, cortical dopamine D1 receptors play a crucial role in taking value-based decisions. In this study, it will be investigated whether value-based decisions in healthy volunteers can be improved by stimulation of D1-receptors. For this purpose, a newly developed dopamine D1-agonist will be used, which selectively increases the activities of frontal D1- and D5-receptors. In this double-blind, randomized, placebo-controlled study, the effects of different single doses of PF-06412562, a not yet licensed D1-agonist, on value-based decision making will be compared with placebo. The use of different dosage strengths will allow to investigate a potential relationship between the extent of activity of the D1-receptor and its influence on behavioral indices. Therefore, four parallel groups will be investigated. Each participant takes in a single dose of either PF-06412562 in different doses or placebo. A screening exam will be carried out 1-3 weeks before the drug intake, and a follow-up examination will be carried out approx. 1 week after the drug intake. At all 3 visits in the study centre, several tests for the investigation of value-based decision making will be carried out.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 8, 2017
Actual (reported)May 12, 2017
Actual (reported)June 9, 2017
Actual (reported)December 20, 2017
Actual (reported)December 20, 2017
Actual (reported)Change from baseline in a delay discounting task.
This validated computer-based decision-making test will be filled in by each participant at three time points during the study: 1-3 weeks before, 5 hours after, and approx. 1 week after a single oral intake of 1 out of 3 possible doses of PF-06412562, or matching placebo.
1-3 weeks before (= baseline), 5 hours after, and approx. 1 week after drug intake.
Change from baseline in a risk discounting task.
This validated computer-based decision-making test will be filled in by each participant at three time points during the study: 1-3 weeks before, 5 hours after, and approx. 1 week after a single oral intake of 1 out of 3 possible doses of PF-06412562, or matching placebo. It will be carried out after the test for outcome 1.
1-3 weeks before (= baseline), 5 hours after, and approx. 1 week after drug intake.
Effect of PF-06412562 on an effort discounting task (compared to placebo).
This validated computer-based decision-making test will be completed by each participant 5 hours after a single oral intake of 1 out of 3 possible doses of PF-06412562, or matching placebo and after having completed the tests for outcome 1 and 2.
5 hours after drug intake.
Effect of PF-06412562 on the Pavlovian to instrumental transfer task (compared to placebo).
This validated computer-based decision-making task tests Pavlovian acquisition and transfer. It will be carried out by each participant immediately after the test in outcome 3.
5 hours after drug intake.
Effect of PF-06412562 on an exploration / exploitation task (compared to placebo).
This validated computer-based decision-making task tests different aspects of value-based decision making. It will be carried out by each participant immediately after the test in outcome 4.
5 hours after drug intake.
Effect of PF-06412562 on a probabilistic reversal learning task (compared to placebo).
This validated computer-based decision-making task tests different aspects of value-based decision making. It will be carried out by each participant immediately after the test in outcome 5.
5 hours after drug intake.
Incidence of treatment-emergent adverse events (safety and tolerability of PF-06412562)
throughout the study and up to 1 week after study drug intake.
Plasma concentrations of PF-06412562
blood sampling 4 hours and 8 hours after the study drug intake.
Single dose of PF-06412562 in low dosage strength
Single dose of PF-06412562 in medium dosage strength
Single dose of PF-06412562 in higher dosage strength
double-blind oral intake of single doses of the aforementioned drug or placebo
double-blind oral intake of single doses of the aforementioned drug or placebo
University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology
Zurich, CH-8091, Switzerland
Soutschek A, Gvozdanovic G, Kozak R, Duvvuri S, de Martinis N, Harel B, Gray DL, Fehr E, Jetter A, Tobler PN. Dopaminergic D1 Receptor Stimulation Affects Effort and Risk Preferences. Biol Psychiatry. 2020 Apr 1;87(7):678-685. doi: 10.1016/j.biopsych.2019.09.002. Epub 2019 Sep 12.
Soutschek A, Kozak R, de Martinis N, Howe W, Burke CJ, Fehr E, Jetter A, Tobler PN. Activation of D1 receptors affects human reactivity and flexibility to valued cues. Neuropsychopharmacology. 2020 Apr;45(5):780-785. doi: 10.1038/s41386-020-0617-z. Epub 2020 Jan 21.
Philippe Tobler, Prof. Dr.
University of Zurich, Dept. of Economics
Alexander Jetter, MD
University of Zurich
120 participants (actual enrollment reported by the registry).
First Submitted
May 12, 2017
First Posted
June 9, 2017
Study Start
May 8, 2017
Actual (reported)D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562
PROJECT 2 EXAMPLE: Feedback X Prevalence Using Dermatology Stimuli
Single dose of placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Soutschek A, Tobler PN. A process model account of the role of dopamine in intertemporal choice. Elife. 2023 Mar 8;12:e83734. doi: 10.7554/eLife.83734.
Primary Completion
December 20, 2017
Actual (reported)Study Completion
December 20, 2017
Actual (reported)Last Updated
November 5, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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