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Oxytocin and Dopamine's Effect on Vicarious Optimism

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ClinicalTrials.gov Identifier: NCT03891095
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
ma, yina, Beijing Normal University

Tracking Information
First Submitted Date  ICMJE March 17, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE December 1, 2018
Actual Primary Completion Date January 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2019)
Belief update value for self, friend and stranger [ Time Frame: 40~70 minutes after drug administration ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxytocin and Dopamine's Effect on Vicarious Optimism
Official Title  ICMJE Oxytocin and Dopamine's Effect on Vicarious Optimism
Brief Summary To investigate the effect of intranasal Oxytocin and L-DOPA's effect on vicarious optimism.
Detailed Description

The current study adopted a double-blind, double-dummy, placebo-controlled mixed design, with Treatment (oxytocin, dopamine, and placebo) as a between-subjects factor, and Target (self, friend, and an identifiable stranger) and Feedback (desirable vs. undesirable) as within-subjects factors. Upon arrival, participants first completed a set of questionnaires, including mood measurements and other questionnaires related to optimistic or prosocial tendency. Participants then self-administered with the pharmacological challenge 40 min before the main task, i.e., the belief updating task where participants indicated and updated their beliefs about the future of oneself, a gender-matched best friend, and a gender-matched identifiable stranger. At the end, participants completed the mood measurement again, as well the debriefing questionnaires which designed to measure their beliefs about the experimental process.

For the vicarious optimism task, participants completed three blocks of the two-session belief updating task where they were asked to estimate the likelihood of adverse life events happening to three targets: themselves (referred as Self), a gender-matched best friend (referred as Friend), and an identifiable stranger (whose name, brief description and picture were presented to the participants to get familiar with before the estimation, such as "The stranger is Zhexing, a 25-year-old male, Chinese"; referred as Stranger).

Participants completed two estimation sessions for one target before beginning with the next target, and the order of targets was counterbalanced across participants within each group. For the first session of each target block, participants were first presented with 30 different adverse life events (in a random order) and estimated the likelihood of each event happening to the target in the future (the 1st estimation, referred to as E1) on a self-paced basis. Participants were then presented with the probability of each event occurring to an average person in a similar environment (Feedback) for 2s. In the second session, participants estimated the likelihood of the same 30 events (in a random order) happening to the target person again without receiving feedback (the 2nd estimation, referred to as E2).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Oxytocin Group
  • L-DOPA Group
  • Placebo Group
Intervention  ICMJE
  • Drug: Oxytocin
    intranasally administrated
  • Drug: L-DOPA
    orally administered
  • Drug: Placebos
    intranasally administrated and orally administered
Study Arms  ICMJE
  • Experimental: Intranasal oxytocin
    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)
    Interventions:
    • Drug: Oxytocin
    • Drug: Placebos
  • Experimental: L-DOPA
    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)
    Interventions:
    • Drug: L-DOPA
    • Drug: Placebos
  • Placebo Comparator: Placebo
    Participants in the Placebo group received spray and oral placebos. 24 IU saline (spray placebo) 187.5 mg calcium carbonate (oral placebo)
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2019)
156
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 16, 2019
Actual Primary Completion Date January 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

  • subjects with past or current psychiatric or neurological disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: we opted to recruit only males for the present study.
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03891095
Other Study ID Numbers  ICMJE OT-DA-Vicarious optimism
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ma, yina, Beijing Normal University
Study Sponsor  ICMJE Beijing Normal University
Collaborators  ICMJE Yale University
Investigators  ICMJE Not Provided
PRS Account Beijing Normal University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP