Effects of Intranasal Oxytocin on Emotion Regulation in Adolescents (ELOREA)

December 15, 2017 updated by: Centre Hospitalier Universitaire de Besancon

Effects of Intranasal Oxytocin on Emotion Regulation to Stressful Interaction in Insecure Adolescents: a Study Protocol for a Double Blind Randomized Controlled Trial

The purpose of this study is to determine the effect of intranasal administration of OT on behavior and discourse of insecure adolescents during a disagreement (stressful situation) with parents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Emotional dysregulation and impaired attachment in adolescence are seen by clinical researchers as potential contributors to development of psychopathology. Recent evidence suggests that administration of intranasal OT may facilitate social interaction by attenuating the stress response to interpersonal conflict. However, to date there have been no studies investigating the effects of intranasal OT on parent-adolescent interaction and on neurophysiological emotional strategies in adolescence. To understand these mechanisms, this study examines the effects of OT on interpersonal emotional regulation in adolescent-parent stressful interaction, and on individual visual and physiological strategies in the visualizing attachment-related emotions pictures.

The main objective will be to evaluate the effect of intranasal administration of OT on behavior and discourse of insecure adolescents during a disagreement (stressful situation) with one of his parents.

Secondary is determine the effect of OT on visual exploration strategies and on the physiological responses (heart rate, galvanic skin response) on images elicited attachment-related emotions in insecure adolescents.

In this randomized, double-blind, placebo-controlled, parallel designs, 60 healthy male adolescents classified with an insecure attachment will receive 24 IU of intranasal OT or placebo, 45 min before the experimental tasks. Adolescent will be invited with his/her parent to an experimental conflict discussion. The conflict session will be videotaped and coded for verbal and nonverbal interaction behavior (e.g., eye contact, nonverbal positive/negative behavior, and self-disclosure) with GPACS. Eye tracking and physiological responses will be recorded simultaneously and continuously during pictures viewing.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Franche-Comté
      • Besançon, Franche-Comté, France, 25000
        • University Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Have a clinical diagnosis of insecure attachment according to the Attachment Scale Interview
  • Male adolescents (and parents) enrolled in high school or college
  • Not hospitalized
  • Without current or past history of neurological or psychiatric illness, including substance abuse or dependence
  • Aged from 13 to 20 years
  • Speaking French
  • Have signed informed consent
  • Affiliation to a French social security

Exclusion Criteria:

  • Females
  • Intellectual deficit
  • Severe neurological symptoms
  • Known allergies to oxytocin or to preservatives in the nasal spray
  • Not speaking French
  • Visual disturbances
  • Chronic disease (liver failure, kidney failure, cardiovascular disease)
  • Antihypertensive therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin
24 IU Oxytocin, 3 puffs per nostril, each with 4 IU OXT, intranasal application 45 min prior to the experiment
Drug: Oxytocin
OT spray will be performed by the research pharmacy at the University Regional Hospital Pharmacy of Besançon. The placebo contained all inactive ingredients except for the neuropeptide. Placebo and OT spray containers will be prepared to look identical and will be counterbalance to be randomly assigned by the pharmacy as well. Double blinding and randomization of patients in the two groups will also be carried out by the pharmacy service. Researchers, as well as participants, will be blinded to the content of the spray. Participants will be instructed to sit and take one puff every 30 seconds, alternating nostrils. Participant will take each dose in front of the clinician to assure correct administration and tolerability.
Other Names:
  • Syntocinon-Spray, Novartis
Placebo Comparator: Placebo
intranasal application, sodium chloride solution, 3 puffs per nostril, 45 min prior to the experiment
Drug: Placebo
The placebo contained all inactive ingredients except for the neuropeptide. Participants will be instructed to sit and take one puff every 30 seconds, alternating nostrils. Participant will take each dose in front of the clinician to assure correct administration and tolerability.
Other Names:
  • Pl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conflict discussion
Time Frame: 3 years
Adolescent will be invited with his/her parent to an experimental conflict discussion. The conflict session will be videotaped and coded for verbal and nonverbal interaction behavior (e.g., eye contact, nonverbal positive/negative behavior, and self-disclosure) with GPACS.Behavioral data will be collected during each of the study visits. Drug effect will be determined by comparing data obtained during placebo and oxytocin visits.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual patterns
Time Frame: 3 years
Adolescent's eye tracking (i.e., time (ms) and frequency of fixations in an AOI) and physiological (Amplitude of SCL (microsiemens), Amplitude of SCRs (microsiemens), Time of latency (s)) responses will be recorded simultaneously and continuously during pictures viewing.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Lauriane Vulliez-Coady, PhD, CHU Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2014

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

December 18, 2017

Last Update Submitted That Met QC Criteria

December 15, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2013/160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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