Vasopressin Effects on Human Social Communication

NCT01327027 | Completed Phase 1 DMC

• 2 other identifiers: 105,108R01MH087721-02
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done because we wish to understand how a chemical produced in the brain, vasopressin, effects emotional social communication processes. Understanding how this system works in normal individuals may help us understand why some people, particularly those with autism and/or antisocial personality disorder, have dysfunctional social interactions. This study will test the effects of 3 doses of arginine vasopressin, delivered intranasally, on physiological and behavioral responses to the faces of same- and other-sex individuals in healthy men and women.

Conditions

Healthy

Keywords

vasopressin; antisocial; affiliation

Outcome Measures

Primary Outcomes (1)

• Emotional Responses

  Physiological and behavioral measures of emotional responses to faces will be measured 30-60 min after the intranasal delivery of the drug. Specifically, electromyographic responses to same- and other-sex faces of two facial muscles, the corrugator supercilli and the zygomaticus major, will be recorded with surface electrodes, as will electrodermal skin conductance responses and heart rate accelerations. Additionally, subjects will be asked to rate how approachable each face is on a scale where -3 is threatening and not approachable and 3 is friendly and approachable.

  60 min

Secondary Outcomes (1)

• Genetic contributions

  4 years

Study Arms (2)

Vasopressin, Arginine, ADH

EXPERIMENTAL

We will test how vasopressin affects emotional responses to facial stimuli in healthy men and women.

Drug: Vasopressin, Arginine, ADH

Sterile Salilne

PLACEBO COMPARATOR

Sterile saline will be administered intranasally and emotional responses to facial stimuli measured.

Drug: Placebo; Sterile Saline

Interventions

Vasopressin, Arginine, ADH DRUG

Vasopressin will be dissolved in sterile saline and intranasally delivered in one of 2 doses to each subject (20IU, 40IU)

Also known as: Arginine, ADH

Vasopressin, Arginine, ADH

Placebo; Sterile Saline DRUG

Sterile saline will be delivered intranasally on a second test day, in counterbalanced order with vasopressin administration.

Also known as: Sterile Saline

Sterile Salilne

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women 21-30 years of age

You may not qualify if:

• individuals with high blood pressure or a history of seizures
• allergies
• heart problems
• psychiatric problems
• drug abuse
• pregnant All subjects will be given a preliminary medical and psychiatric exam as well as drug and (for women) pregnancy test

Sponsors & Collaborators

• Bowdoin College: lead
• MaineHealth: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Maine Medical Center, McGeachey Hall, OP Psych

Portland, Maine, 04102, United States

Location

Related Publications (1)

• Price D, Burris D, Cloutier A, Thompson CB, Rilling JK, Thompson RR. Dose-Dependent and Lasting Influences of Intranasal Vasopressin on Face Processing in Men. Front Endocrinol (Lausanne). 2017 Sep 22;8:220. doi: 10.3389/fendo.2017.00220. eCollection 2017.

  PMID: 29018407 RESULT

MeSH Terms

Conditions

Diabetes Insipidus; Antisocial Personality Disorder

Interventions

Vasopressins; Arginine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Amino Acids, Basic; Amino Acids; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Richmond Thompson, Ph.D.

  Bowdoin College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Maine Medical Pharmacy prepared drug and placebo doses; when subjects were enrolled, the pharmacy randomly assigned the subject to a condition, and gave the unmarked nasal applicator to the subject, who was accompanied by the nurse/technician. Neither the subject nor the nurse/technician collecting data knw whether it was placebo or drug, nor which dose (20IU or 40IU) the subject would be receiving on the drug day.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Associated Professor

Model Details: In the work at Maine Medical, each subject received one of two doses of vasopressin (20IU or 40IU) on one test day, and placebo (sterile saline) on the other, in counterbalanced order. All subjects reported back for a 3rd day, 2-21 days after the 2nd test day, for a third test when no drug was administered. Because preliminary data analysis suggested the drug may have longer lasting, generalized effects on behavioral responses than anticipated, the second study done at Emory University with a single dose and in which subjects were also tested in fMRI, was changed to between-subjects design in which each subject either received placebo or 40IU on an initial test day and were then tested on a follow up test, 2-21 days later, when no drug was given.

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 1, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)