Effects of Oxytocin on Negative Symptoms and Social Cognition in Schizophrenia and Its Possible Mechanisms
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of oxytocin on negative symptoms and
      social cognitive task performance in schizophrenia. The investigators conducted a randomized,
      placebo-controlled trial testing the effects of twice daily intranasal oxytocin treatment for
      14 days on psychotic symptoms and social cognition in patients with schizophrenia. The
      investigators hypothesize that PANSS scores will decline significantly and several social
      cognition measures will improved significantly or nearly significantly in oxytocin but not
      placebo recipients.
    

Detailed description: 
      Social impairment is a primary cause of disability in schizophrenia, responds poorly to
      current antipsychotic medications and is related to deficits in social cognitive abilities,
      which include Theory of Mind, emotion recognition and attributional style. Oxytocin (OT) has
      many pro-social effects in animals and antipsychotic-like efficacy in preclinical tests. In
      this study, the investigators conducted a randomized, placebo-controlled trial testing the
      effects of twice daily intranasal oxytocin treatment for 14 days on psychotic symptoms and
      social cognition in patients with schizophrenia. The investigators will recruit patients with
      schizophrenia, screening of subjects included a review of psychiatric and medical history,
      physical examination, baseline social cognition measures were obtained followed by
      psychiatric ratings. Daily intranasal treatments were initiated after baseline assessments.
      Social cognition measures and psychiatric ratings were repeated beginning 50 min after the
      morning dose of study medication on treatment day 14. psychiatric ratings include The
      Positive and Negative Syndrome Scale (PANSS) and The Clinical Assessment Interview for
      Negative Symptoms (CAINS). The social cognition instruments are some social scales such as
      Toronto Alexithymia Scale, the Interpersonal Reactivity Index(IRI), and some computer tests
      such as reinforcement learning task and facial emotion identification test.
    

Intervention name(s): Oxytocin; Saline
Intervention type(s): Drug; Drug
Intervention description(s): It's a two-week treatment trial.Subjects self-administer intranasal study drug twice daily; before breakfast and before dinner. Each dose consists of six 0.1 ml insufflations (alternating between the left and right nostril) of OT spray containing approximately 24 international units of OT; It's a two-week treatment trial. Subjects self-administer intranasal study drug twice daily; before breakfast and before dinner. Each dose consists of six 0.1 ml insufflations (alternating between the left and right nostril) of saline spray containing approximately 24 international units of saline
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia; negative symptoms; oxytocin