NCT03846271

Brief Summary

The main aim of the study is to investigate whether intranasal oxytocin (24IU) influences reward sensitivity and performance monitoring during reinforcement learning.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

January 25, 2019

Last Update Submit

February 17, 2019

Conditions

Learning Disabilities

Keywords

Oxytocinperformance monitoringreinforcement learning

Outcome Measures

Primary Outcomes (2)

  • Neural index: Event-related potential: Feedback Related Negativity (FRN) during acquisition phase

    Feedback Related Negativity (FRN): a negative ERP component evoked by negative feedback relative to positive feedback during the acquisition phase will be compared between the oxytocin and placebo treatment conditions.

    45-105 minutes after treatment administration

  • Neural index: Event-related potential: Error Related Negativity (ERN) during the test phase

    Error Related Negativity (ERN): a negative ERP component evoked by incorrect responses relative to correct responses during the test phase will be compared between the oxytocin and placebo treatment conditions.

    45-105 minutes after treatment administration

Secondary Outcomes (5)

  • Behavioral index: Response accuracy to superior stimuli during the acquisition phase

    45-105 minutes after treatment administration

  • Behavioral index: Response accuracy to stimuli associated with highest probability positive feedback during the test phase

    45-105 minutes after treatment administration

  • Response accuracy avoiding stimuli associated with highest probability negative feedback in the test phase.

    45-105 minutes after treatment administration

  • Response accuracy in response to superior stimuli associated with relative higher probability positive feedback in the test phase.

    45-105 minutes after treatment administration

  • Response accuracy avoiding stimuli associated with higher probability negative feedback in the test phase.

    45-105 minutes after treatment administration

Study Arms (2)

Oxytocin then placebo

EXPERIMENTAL

Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo.

Drug: intranasal oxytocinDrug: intranasal placebo

Placebo then oxytocin

EXPERIMENTAL

Participants first receive placebo. After a washout period of 2 weeks, they receive oxytocin (24 IU).

Drug: intranasal oxytocinDrug: intranasal placebo

Interventions

intranasal oxytocinDRUG

24 IU of oxytocin nasal spray will be applied to each subject.

Oxytocin then placeboPlacebo then oxytocin
intranasal placeboDRUG

an identical amount of placebo nasal spray will be applied to each subject.

Oxytocin then placeboPlacebo then oxytocin

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-30
  • Male sex
  • Right handedness

You may not qualify if:

  • History of brain injury
  • Current or history of psychiatric, neurological or internist disorder
  • Current or regular use of medication, psychotropic substances, including nicotine
  • Contraindications for Oxytocin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China(UESTC)

Chengdu, Sichuan, 611731, China

RECRUITING

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Keith Kendrick, PhD

    University of Electronic Science and Technology of China(UESTC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuang Qian, MD

CONTACT

13086663679zq19910362@126.com

Benjamin Becker, PhD

CONTACT

86-28-61830988ben_becker@gmx.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized placebo-controlled double-blind within-subject design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 19, 2019

Study Start

December 4, 2018

Primary Completion

March 31, 2019

Study Completion

July 31, 2019

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

CN(1)