Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia?
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Individuals with schizophrenia have been found to have deficits in social cognition, which is
      defined as the functions that are engaged during social interactions. Social cognition has
      been found to be critical in predicting multiple aspects of community functioning. There are
      no currently available medications that have been consistently found to improve social
      cognition in individuals with schizophrenia. Oxytocin functions as a neurotransmitter that is
      thought to be involved in multiple aspects of social behavior and related emotions. In this
      study, we test the hypothesis that acute administration of intranasal oxytocin will improve
      social cognition in individuals with schizophrenia.
    

Detailed description: 
      Schizophrenia is characterized by the presence of positive symptoms (delusions,
      hallucinations, disorganization of thought process and behavior) as well as negative symptoms
      (blunted affect, alogia, and avolition), neurocognitive deficits, and impaired social
      cognition. While positive symptoms can often respond well to antipsychotic medications, the
      latter symptoms are more difficult to treat. In this study, we will focus on social
      cognition, which is defined as the functions that are engaged during social interactions.
      Social cognition has been categorized into four main domains: theory of mind, social
      perception, attributional bias, and emotional processing. Social cognition in patients with
      schizophrenia has been found to be critical in predicting multiple aspects of community
      functioning. There are currently two broad approaches to improve social cognition in patients
      with schizophrenia: pharmacological and psychosocial interventions. While psychosocial
      interventions (training exercises to target improvement in domains of social cognition) have
      shown some benefit, their resultant improvements have been limited in their distribution
      across multiple domains as well as their generalization to improved functioning in the
      community. Pharmacological trials have yielded mixed results, and there are not any currently
      available medications that have been consistently found to improve social cognition in
      patients with schizophrenia2. One potential future therapeutic target for enhancing social
      cognition is the oxytocin system.

      Oxytocin is a nine-amino acid peptide that, in addition to its role in the periphery for
      regulating lactation and uterine contractions, functions centrally as a neurotransmitter
      which is involved in multiple aspects of social behavior and related emotions. Specifically,
      it has been found to modulate emotion recognition, trust, eye contact, empathic accuracy, as
      well as envy and gloating. Given oxytocin's role in social functioning, in conjunction with
      the deficits in social functioning found frequently in individuals with schizophrenia, there
      have been several studies over the past three decades examining the oxytocin system in humans
      with schizophrenia and in rodent experimental models.

      It has been found that individuals with schizophrenia do not show the same level of increase
      in oxytocin as normal controls in response to trust-related interpersonal interactions, and
      low plasma oxytocin predicted negative symptoms of schizophrenia. Additionally, it has also
      been found that plasma oxytocin levels predicted the ability of patients with schizophrenia
      to identify facial expressions. Finally, it has been found recently that sustained regular
      administration of intranasal oxytocin significantly reduced both positive and negative
      symptoms of schizophrenia. Thus, there is significant evidence supporting further research
      studying the effect of oxytocin on social cognition. It is not yet known if exogenous
      administration of oxytocin will have acute effects on neuropsychological measures of social
      cognition in individuals with schizophrenia, and this is the focus of this proposed pilot
      study.

      The overall hypothesis guiding this study is that acute oxytocin administration will improve
      social cognition (as assessed by a composite score comprising two measures of "low level"
      social cognitive processes and two measures of "high level" social cognitive processes) in
      individuals with schizophrenia. Our primary goals are to assess the feasibility of this
      experimental paradigm and to generate pilot data and obtain estimates of effect sizes which
      can be used in planning future larger studies.
    

Intervention name(s): Oxytocin; Inactive placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time; A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Social Intelligence; Perception, Social; Oxytocin