NCT00914953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 2, 2012

Status Verified

February 1, 2012

Enrollment Period

10 months

First QC Date

June 4, 2009

Last Update Submit

February 29, 2012

Conditions

Social Activity

Keywords

social isolationcooperative behaviordepressionlonelinesshappinessempathy

Outcome Measures

Primary Outcomes (1)

  • confirm increased social activities in treatment condition compared to control condition via self-report.

    30 days

Secondary Outcomes (1)

  • Evidence of greater psychological health for treatment condition as compared to control condition.

    30 days

Study Arms (1)

oxytocin

EXPERIMENTAL
Drug: oxytocin (Pitocin)

Interventions

oxytocin (Pitocin)DRUG

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

oxytocin

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • residentially housed
  • English fluency

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linda Valley Villa

Loma Linda, California, 92354-3135, United States

Location

MeSH Terms

Conditions

Social IsolationCooperative BehaviorDepression

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 5, 2009

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

March 2, 2012

Record last verified: 2012-02

Locations

US(1)