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Oxytocin and Social Behavior Over the Lifespan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914953
First Posted: June 5, 2009
Last Update Posted: March 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paul J. Zak, Claremont Graduate University
  Purpose
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 Intervention Phase
Social Activity Drug: oxytocin (Pitocin) Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Paul J. Zak, Claremont Graduate University:

Primary Outcome Measures:
  • confirm increased social activities in treatment condition compared to control condition via self-report. [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Evidence of greater psychological health for treatment condition as compared to control condition. [ Time Frame: 30 days ]

Enrollment: 41
Study Start Date: February 2010
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxytocin Drug: oxytocin (Pitocin)
40 IU OT intranasally (IN) once-daily for 10 consecutive days

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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): NCT00914953


Locations
United States, California
Linda Valley Villa
Loma Linda, California, United States, 92354-3135
Sponsors and Collaborators
Claremont Graduate University
  More Information

Responsible Party: Paul J. Zak, Professor, Claremont Graduate University
ClinicalTrials.gov Identifier: NCT00914953     History of Changes
Other Study ID Numbers: CNS-R21AG029871
NIH Grant 1R21AG029871-01A2
First Submitted: June 4, 2009
First Posted: June 5, 2009
Last Update Posted: March 2, 2012
Last Verified: February 2012

Keywords provided by Paul J. Zak, Claremont Graduate University:
social isolation
cooperative behavior
depression
loneliness
happiness
empathy

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