Effects of Intranasal Oxytocin on Emotion Regulation in Adolescents

NCT02301715 | Completed Phase 1 DMC

• 1 other identifier: P/2013/160
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotion; Parent-Child Relations

Keywords

Intranasal oxytocin; Emotion regulation; Attachment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual patterns

  3 years

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

24 IU Oxytocin, 3 puffs per nostril, each with 4 IU OXT, intranasal application 45 min prior to the experiment

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

intranasal application, sodium chloride solution, 3 puffs per nostril, 45 min prior to the experiment

Drug: Placebo

Interventions

Oxytocin DRUG

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.

Also known as: Syntocinon-Spray, Novartis

Oxytocin

Placebo DRUG

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.

Also known as: Pl

Placebo

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

University Regional Hospital

Besançon, Franche-Comté, 25000, France

Location

MeSH Terms

Conditions

Emotional Regulation

Interventions

Oxytocin; lactitol

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Lauriane Vulliez-Coady, PhD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: April 29, 2014
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

FR (1)