Effects of Oxytocin Nasal Spray on Social Affiliation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Maryland
Sponsor:
Collaborator:
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT00663039
First received: April 17, 2008
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positive symptoms, fail to benefit negative symptoms, the focus of the current protocol. One of the strategies of novel drug development depends on identifying heritable physiological deficits that mark the disease liability and are thought to occur along the causal pathway of negative symptoms. These heritable physiological deficits are often found in the biological relatives of schizophrenia proband; particularly those who have schizophrenia related personality styles [defined by schizophrenia spectrum personalities (SSP) in the diagnostic system], even though they do not have the full-blown illness. The current protocol will pilot a strategy of targeting biomarkers of negative symptoms using intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such non-clinical sample have several advantages including the absence of other drug treatment that may modulate the response, and the lack of generalized deficits causing problems with task comprehension/engagement that may mute the therapeutic signal. In addition, finding of efficacy of the experimental drug on the target physiological deficit and the associated symptoms has clinical implications on its own rights. This is because about 25% of subjects with schizophrenia spectrum personality disorders experience serious functional impairments.

Oxytocin is an extensively used drug, which is well tolerated with few serious side effects. Several lines of evidence suggest its putative role in the treatment of negatives symptoms, particularly a lack of social drive and related symptoms.


Condition Intervention Phase
Schizophrenia
Drug: Oxytocin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effects of Oxytocin Nasal Spray on Social Affiliation

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Social Affiliation measured by Social Affiliative Role Play [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    In a vedeotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale.


Secondary Outcome Measures:
  • Cognitive (memory and attention) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Oculomotor Delayed Response task and Continuous Performance task will be administered to examine the effects on working memory and attention.


Estimated Enrollment: 24
Study Start Date: October 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Oxytocin
Drug: Oxytocin
24 IU oxytocin (or Placebo) in a total of 6 puffs (3 puffs per nostril)
Other Names:
  • Pitocin
  • Syntocinon
Placebo Comparator: 2 Drug: Placebo
Single dose (plus a booster dose) drug probe study using intranasal placebo

Detailed Description:

The current study will examine the effects of intranasal oxytocin on physiological/cognitive markers of negative symptoms in 24 participants with schizophrenia spectrum traits. Subjects will be tested in two one-day studies carried out at least a month apart. Subjects will receive a 24 IU dose of intranasal oxytocin (or placebo) followed by a battery of cognitive/neurophysiological tests administered 50 minutes later completed over the next 155 minutes. A second dose of the drug (oxytocin or placebo) will be administered 2 hours after the 1st in order to maintain therapeutic plasma levels and to complete all testing.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male/Female subjects between ages of 18-64 years
  • The presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits)
  • The presence of visuo-spatial working memory impairment as defined by error in the oculomotor delayed response (ODR) task of more than 0.5 SD above the mean values in healthy control subjects
  • Relative of an individual with schizophrenia, schizo-affective, or schizophreniform disorder
  • Able to provide written informed consent. Females are excluded due to risk of discomfort and unblinding due to potential uterine cramps induced by oxytocin.

Exclusion Criteria:

  • Subjects meeting criteria for a life-time diagnosis of any one of the DSM IV, Axis I psychotic disorders (exceptions being a single past episode of major depressive disorder with psychotic features or psychotic symptoms associated with substance abuse with the substance abuse ending 6-months prior to study participation) (this is for the SSP recruitment)
  • Subjects meeting DSM-IV criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
  • Medical conditions that preclude participation in drug trials or assessments of outcome measures (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders)
  • Received any investigational drug in the preceding four weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663039

Contacts
Contact: Matt Glassman 410-402-6823 mglassman@mprc.umaryland.edu
Contact: Dawn Detamore 410-402-6820 ddetamor@mprc.umaryland.edu

Locations
United States, Maryland
Maryland Psychiatric Research Center Recruiting
Catonsville, Maryland, United States, 21228
Contact: L I Hong, M.D.    410-402-6828    ehong@mprc.umaryland.edu   
Contact: Dawn Detamore    410-402-6820    ddetamor@mprc.umaryland.edu   
Sub-Investigator: Robert Buchanan, M.D.         
Sub-Investigator: Ikwunga Wonodi, M.D.         
Sub-Investigator: L. E. Hong, M.D.         
Sub-Investigator: William T Carpenter, MD         
Sub-Investigator: James Gold, PhD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Henry Holcomb, M.D. University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: MPRC, L. Elliot Hong, M.D., University of Maryland
ClinicalTrials.gov Identifier: NCT00663039     History of Changes
Other Study ID Numbers: HP-00043595, P50MH082999
Study First Received: April 17, 2008
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Maryland:
Schizophrenia
Eye movements
phenotype
biochemical
relatives

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014