NCT03891095

Brief Summary

To investigate the effect of intranasal Oxytocin and L-DOPA's effect on vicarious optimism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

March 17, 2019

Last Update Submit

March 24, 2019

Conditions

Keywords

intranasal oxytocinL-DOPAVicarious optimism

Outcome Measures

Primary Outcomes (1)

  • Belief update value for self, friend and stranger

    In the vicarious optimistic bias task, participants would make first estimation about the happening likelihood for each event for themselves, friend, and stranger and then receive feedback about the general likelihood of each event happened in future. After all events first estimation, participants would estimate all the event again. So, for the belief update, we used the second estimation value to minus the first estimation value to get the update value, as well as calculating the update value in desirable condition (first estimation \< feedback) and undesirable condition (first estimation \< feedback). Then investigated the general belief updating (gBU) and optimistic belief updating (using desirableBU-undesirableBU) for the three target (self vs. friend vs. stranger) in three treatment groups (Oxytocin vs. L-DOPA vs. Placebo)

    40~70 minutes after drug administration

Study Arms (3)

Intranasal oxytocin

EXPERIMENTAL

Oxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety. Subjects receiving an intranasal spray of OXT (24 IU or 40.32 mg; Syntocinon-spray; Novartis, Switzerland)

Drug: OxytocinDrug: Placebos

L-DOPA

EXPERIMENTAL

L-DOPA, a neuropeptide who is a key modulator of complex socioaffective responses including reward, social decision making, learning. Subjects receiving 187.5 mg Madopar (L-DOPA treatment, including 150 mg L-3,4-dihydroxyphenylalanine, together with 37.5 mg benserazide, which promotes higher levels of dopamine in the brain while minimizing side effects from peripheral dopamine)

Drug: L-DOPADrug: Placebos

Placebo

PLACEBO COMPARATOR

Participants in the Placebo group received spray and oral placebos. 24 IU saline (spray placebo) 187.5 mg calcium carbonate (oral placebo)

Drug: Placebos

Interventions

intranasally administrated

Intranasal oxytocin
L-DOPADRUG

orally administered

L-DOPA

intranasally administrated and orally administered

Intranasal oxytocinL-DOPAPlacebo

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility Detailswe opted to recruit only males for the present study.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy subjects without past or current psychiatric or neurological disorders

You may not qualify if:

  • subjects with past or current psychiatric or neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Normal University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

OxytocinLevodopa

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsTyrosine

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 26, 2019

Study Start

December 1, 2018

Primary Completion

January 15, 2019

Study Completion

January 16, 2019

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations