Oxytocin and Social Cognition in Schizophrenia
Condition: Social Cognition; Social Anxiety; Emotional Intelligence
MeSH terms: Schizophrenia
Intervention: Oxytocin; Placebo
Intervention description: Oxytocin given as 20 IU BID; Placebo given as 20 IU BID
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Social Cognition; Schizophrenia; Oxytocin

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.
    

Eligibility 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.