- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00914953
Oxytocin and Social Behavior Over the Lifespan
February 29, 2012 updated by: Paul J. Zak, Claremont Graduate University
Oxytocin and Social Behavior Over the Lifespan: Interventional Study
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
41
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Loma Linda, California, United States, 92354-3135
- Linda Valley Villa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: oxytocin
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40 IU OT intranasally (IN) once-daily for 10 consecutive days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
confirm increased social activities in treatment condition compared to control condition via self-report.
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evidence of greater psychological health for treatment condition as compared to control condition.
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
June 4, 2009
First Submitted That Met QC Criteria
June 4, 2009
First Posted (Estimate)
June 5, 2009
Study Record Updates
Last Update Posted (Estimate)
March 2, 2012
Last Update Submitted That Met QC Criteria
February 29, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNS-R21AG029871
- NIH Grant 1R21AG029871-01A2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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