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Decision MakingPhase 1NCT03181841

Effects of PF-06412562 on Value-based Decision-making in Healthy Individuals

A Phase 1 study testing PF-06412562 in people with Decision Making, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Decision Making
What is being tested?
PF-06412562
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSwitzerland
Study dates
8 May 2017to 20 Dec 2017
Phase
Phase 1
Are there results?
None posted in the registry

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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Informed Consent as documented by signature on the informed consent form
  • Physically and psychiatrically healthy men and women
  • Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days for females and 90 days for males after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children.
  • Female subjects of non childbearing potential must meet at least one of the following criteria:
  • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  • Have medically confirmed ovarian failure or;
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  • Achieved post menopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the post menopausal state.
  • All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
  • Aged 18-35 years
  • Negative pregnancy test (see exclusion criteria)
  • Normal or corrected-to-normal vision

Who cannot join

  • Pregnant female subjects; breastfeeding female subjects
  • considered to be healthy based on an extensive pre-study screening including anamnesis, physical examination, laboratory investigations, vital signs, ECG, etc.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: Effects of PF-06412562 on Value-based Decision-making in Healthy Individuals: a Mono-center, Randomized, Placebo Controlled, Double-blind Study (Phase I)

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.

Conditions
Decision Making
Being tested
PF-06412562, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06412562Drug

    double-blind oral intake of single doses of the aforementioned drug or placebo

  • PlaceboDrug

    double-blind oral intake of single doses of the aforementioned drug or placebo

Study groups in NCT03181841
Study groupRoleWhat they receive
Active dose 1ExperimentalSingle dose of PF-06412562 in low dosage strength
Receives: Drug: PF-06412562
Active dose 2ExperimentalSingle dose of PF-06412562 in medium dosage strength
Receives: Drug: PF-06412562
Active dose 3ExperimentalSingle dose of PF-06412562 in higher dosage strength
Receives: Drug: PF-06412562
PlaceboPlacebo comparatorSingle dose of placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1-3 weeks before (= baseline), 5 hours after, and approx. 1 week after drug intake.

  2. 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.

    Measured: 1-3 weeks before (= baseline), 5 hours after, and approx. 1 week after drug intake.

  3. 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.

    Measured: 5 hours after drug intake.

  4. 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.

    Measured: 5 hours after drug intake.

  5. 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.

    Measured: 5 hours after drug intake.

  6. 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.

    Measured: 5 hours after drug intake.

Secondary outcomes (1)

  1. Incidence of treatment-emergent adverse events (safety and tolerability of PF-06412562)

    continuous assessment of adverse events by non-leading questions, repeated safety laboratory tests, repeated ECGs, repeated control of vital parameters.

    Measured: throughout the study and up to 1 week after study drug intake.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2017
  2. Study start8 May 2017
  3. Primary completion20 Dec 2017
  4. Study completion20 Dec 2017

Resources

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 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03181841
Sponsor's protocol ID
PHA-16-D1AGO-01
Status last verified
Nov 2020
First submitted
12 May 2017
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31668477

  • 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.

    PubMed 31962344

  • 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.

    PubMed 36884013

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06412562 in people with Decision Making, run by University of Zurich at 1 site in Switzerland.

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 11 inclusion and 2 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 5 Nov 2020. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in a delay discounting task. (time frame: 1-3 weeks before (= baseline), 5 hours after, and approx. 1 week after drug intake.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03181841, which also lists 3 linked publications.

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 5 Nov 2020.

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