Working… Menu

Oxytocin and Social Cognition in Schizophrenia

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. Identifier: NCT00884897
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : June 1, 2017
Last Update Posted : October 2, 2019
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
MPRC, University of Maryland, Baltimore

Brief Summary:

Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in patients with schizophrenia and these are not remediated by antipsychotic medications or psychosocial interventions. Social cognition is associated with functional outcome, an important step in striving for recovery in this population. The hormone and neurotransmitter, oxytocin, which has been associated with social bonding and trust has been shown to improve measures of some aspects of social cognition in humans. The study will assess the effect of acute administration of intranasal oxytocin on measures of social cognition and functioning as well as on emotional intelligence and symptoms.

Study population: The study population will include patients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6 weeks. We will enroll a total of 30 subjects (N=15 placebo and N=15 oxytocin groups).

Experimental design and methods: After a one week lead in phase, participants will undergo 3 weeks of oxytocin (20 IU BID) or placebo administration (double blind) in addition to their existing medication regimen. Outcome measures will be administered during the lead in phase, and at the end of the study drug administration phase (under the acute effect of OT). The primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Maryland Assessment of Social Competence (MASC). Secondary measures include rating from the domains of social cognition (emotion perception, attributional style, theory of mind and social perception), symptom rating and measures of social anxiety and quality of life. Side effects and symptoms will be measured weekly.

Condition or disease Intervention/treatment Phase
Social Cognition Social Anxiety Emotional Intelligence Drug: Oxytocin Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxytocin and Social Cognition in Schizophrenia
Study Start Date : January 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Drug: Oxytocin
Oxytocin given as 20 IU BID

Placebo Comparator: Placebo
We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Drug: Placebo
Placebo given as 20 IU BID

Primary Outcome Measures :
  1. To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients [ Time Frame: participants are assessed at baseline and end point ]
    Mayer-Salovay Caruso Emotional Intelligence Test (Mayer et al., 2002; MSCEIT) This is a self report instrument that consists of 141 items and 8 ability subscales, which assess four components (branches) of emotion processing: identifying emotions, using emotions, understanding emotions, and managing emotions. For this study we will focus on the managing emotions and understanding emotions components. There are 29 total items assessed with a total score ranging from 5-145. The higher the score the better the outcome.

Secondary Outcome Measures :
  1. To Determine Whether OT Improves Measures of Social Anxiety. [ Time Frame: Outcomes are compared between Baseline and endpoint ]
    To determine whether OT improves measures of social anxiety as measured by the Social Interaction Anxiety Scale. This assessment has 20 items scored 0-4 for a total minimum score of 0 and maximum score of 80. The lower the score the better the outcome.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

All participants must:

  1. Be between age 18 and 55.
  2. Meet DSM-IV criteria for Schizophrenia or Schizoaffective Disorder.
  3. Treated with a stabilized antipsychotic regimen (i.e., have had no change in antipsychotic medication in the previous six weeks and no change in dose for the past 30 days).

Exclusion criteria:

Participants will be excluded if they have evidence of:

  1. DSM-IV criteria for substance dependence in the last 6 months or DSM-IV criteria for abuse in the past 30 days.
  2. Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires. This is defined an as a score of less than 10 on the Evaluation to Sign Consent (ESC) and judged by the treating clinician.
  3. Medical illness that in the view of the investigators would compromise participation in research.
  4. History of polydipsia and/or hyponatremia
  5. Clinically significant endocrine disorders, as judged by the PI. Abnormalities in prolactin levels and thyroid function tests associated with the use of dopamine antagonist medications will not be exclusionary.
  6. Pregnancy, planning to become pregnant, or breastfeeding. In addition, women of childbearing age are required to use an effective form of birth control for the duration of the study. Effective forms of birth control include:

    • hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones),
    • surgical sterility (tubal ligation or hysterectomy)
    • IUD
    • Diaphragm with spermicide
    • Condom with spermicide
    • Abstinence
  7. Use of any drugs (prostaglandins, vasoconstricting agents or anesthetic medications, for example) that may interact with oxytocin. Justification: Avoidance of adverse interaction with oxytocin. Assessment tool(s): Clinical interview and toxicology screen
  8. History of hypersensitivity to oxytocin or vehicle, i.e. propyl parahydroxybenzoate, methyl parahydroxybenzoate, chlorobutanol hemihydrate. Assessment tool: clinical interview
  9. Presence of or history of clinically significant allergic rhinitis as assessed by the PI, M.D., or Nurse. Justification: Inflammation of nasal mucosa could interfere with mucosal absorption of intranasally administered OT. Current rhinitis from an upper respiratory infection should be resolved prior to enrollment in study.

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 identifier (NCT number): NCT00884897

Layout table for location information
United States, Maryland
Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland, Baltimore
National Institute on Drug Abuse (NIDA)
Layout table for investigator information
Principal Investigator: Deanna L Kelly, Pharm.D, BCPP University of Maryland, College Park
Principal Investigator: Mary Lee, MD National Institute on Drug Abuse (NIDA)
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: MPRC, Deanna L. Kelly, Pharm.D., BCPP, University of Maryland, Baltimore Identifier: NCT00884897    
Other Study ID Numbers: HP-00041024
P50MH082999 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2009    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: October 2, 2019
Last Verified: September 2019
Keywords provided by MPRC, University of Maryland, Baltimore:
Social Cognition
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Reproductive Control Agents
Physiological Effects of Drugs