Oxytocin and Social Cognition in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT00884897
First received: April 20, 2009
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Social Cognition
Social Anxiety
Emotional Intelligence
Drug: Oxytocin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxytocin and Social Cognition in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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 weekly for 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether OT improves measures of social function, well-being and social anxiety. [ Time Frame: participants are assessed weekly for 4 weeks ] [ Designated as safety issue: No ]
  • To determine the relationship between aspects of social cognition and functional outcome measures as a function of OT administration [ Time Frame: participants are assessed weekly for 4 weeks ] [ Designated as safety issue: No ]
  • Determine relationship between baseline serum OT levels and baseline measures of social cognition and emotional intelligence [ Time Frame: participants are assessed weekly for 4 weeks ] [ Designated as safety issue: No ]
  • To determine whether repeated administration of OT changes endogenous plasma levels after repeated administration [ Time Frame: participants are assessed weekly for 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00884897

Locations
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
Investigators
Principal Investigator: Deanna L Kelly, Pharm.D, BCPP University of Maryland
Principal Investigator: Mary Lee, MD National Institute on Drug Abuse (NIDA)
  More Information

No publications provided by University of Maryland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MPRC, Deanna L. Kelly, Pharm.D., BCPP, University of Maryland
ClinicalTrials.gov Identifier: NCT00884897     History of Changes
Other Study ID Numbers: HP-00041024
Study First Received: April 20, 2009
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
Social Cognition
Schizophrenia
Oxytocin

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

ClinicalTrials.gov processed this record on August 18, 2014