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

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ClinicalTrials.gov Identifier: NCT02301715
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Emotion Parent-Child Relations Drug: Oxytocin Drug: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Intranasal Oxytocin on Emotion Regulation to Stressful Interaction in Insecure Adolescents: a Study Protocol for a Double Blind Randomized Controlled Trial
Actual Study Start Date : April 29, 2014
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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 Name: 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 Name: Pl




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301715


Locations
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France
University Regional Hospital
Besançon, Franche-Comté, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Lauriane Vulliez-Coady, PhD CHU Besançon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02301715     History of Changes
Other Study ID Numbers: P/2013/160
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Intranasal oxytocin
Emotion regulation
Attachment

Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs