Oxytocin and Social Behavior Over the Lifespan

Sponsor

Claremont Graduate University (Other)

Overall Status

Completed

CT.gov ID

NCT00914953

Collaborator

(none)

Enrollment

Location

Arm

21.9

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate if intranasal oxytocin (a hormone naturally produced in the body) promotes motivation for, and engagement in, social activities in older adults.

Condition or Disease	Intervention/Treatment	Phase
Social Activity	Drug: oxytocin (Pitocin)	Early Phase 1

Detailed Description

Using a double-blind and placebo controlled design, this study seeks to determine if a short course of exogenous oxytocin (OT) will induce changes in social activities in residentially housed older adults (OAs) during a 10-day treatment period, and after it ends. Because OT is associated with peri-reproductive behaviors, OT release in OAs is expected to be attenuated relative to younger adults. If OT release is low in OAs as we hypothesize, augmenting OT may increase their desire for social interactions, increase the frequency of participation in social activities and augment the number of and quality of social ties, thereby providing protection against disease, early death, cognitive decline, and depression. Research in rodents suggests that social interactions themselves may change chronic OT levels (Carter & Keverne, 2002; Carter & Altemus, 1997), in a positive feedback loop. In order to demonstrate OT as the causal mechanism, we propose to infuse oxytocin and then track the desire for, quantity of, and quality of social activities.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Oxytocin and Social Behavior Over the Lifespan: Interventional Study

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: oxytocin	Drug: oxytocin (Pitocin) 40 IU OT intranasally (IN) once-daily for 10 consecutive days

Arm

Intervention/Treatment

Experimental: oxytocin

Drug: oxytocin (Pitocin)

40 IU OT intranasally (IN) once-daily for 10 consecutive days

Outcome Measures

Primary Outcome Measures

confirm increased social activities in treatment condition compared to control condition via self-report. [30 days]

Secondary Outcome Measures

Evidence of greater psychological health for treatment condition as compared to control condition. [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

residentially housed
English fluency

Exclusion Criteria:

non ambulatory
severe psychiatric problems presently or in the recent past
severe medical problems (e.g., cancer, diabetes, advanced heart disease)
irregular heart beat
treatment using psychoactive medications (other than antiepileptics, mood stabilizers, or Ambien)
inability to adequately communicate with the research team
treatment with an experimental drug
excessive fatigue suggesting hypothyroidism