Effects of Intranasal Oxytocin on Emotion Regulation in Adolescents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Emotion, Parent-Child Relations

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br>24 IU Oxytocin, 3 puffs per nostril, each with 4 IU OXT, intranasal application 45 min prior to the experiment | Drug: Oxytocin<br>* 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.<br>* Other names: Syntocinon-Spray, Novartis;|
| Placebo Comparator: Placebo<br>intranasal application, sodium chloride solution, 3 puffs per nostril, 45 min prior to the experiment | Drug: Placebo<br>* 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.<br>* Other names: Pl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conflict discussion | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attachment, Intranasal oxytocin, Emotion regulation