Effects of Oxytocin Nasal Spray on Social Affiliation
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom
      domains and functional impairments. Existing treatments of schizophrenia, although effective
      against positive symptoms, fail to benefit negative symptoms, the focus of the current
      protocol. One of the strategies of novel drug development depends on identifying heritable
      physiological deficits that mark the disease liability and are thought to occur along the
      causal pathway of negative symptoms. These heritable physiological deficits are often found
      in the biological relatives of schizophrenia proband; particularly those who have
      schizophrenia related personality styles [defined by schizophrenia spectrum personalities
      (SSP) in the diagnostic system], even though they do not have the full-blown illness. The
      current protocol will pilot a strategy of targeting biomarkers of negative symptoms using
      intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such
      non-clinical sample have several advantages including the absence of other drug treatment
      that may modulate the response, and the lack of generalized deficits causing problems with
      task comprehension/engagement that may mute the therapeutic signal. In addition, finding of
      efficacy of the experimental drug on the target physiological deficit and the associated
      symptoms has clinical implications on its own rights. This is because about 25% of subjects
      with schizophrenia spectrum personality disorders experience serious functional impairments.

      Oxytocin is an extensively used drug, which is well tolerated with few serious side effects.
      Several lines of evidence suggest its putative role in the treatment of negatives symptoms,
      particularly a lack of social drive and related symptoms.
    

Detailed description: 
      The current study will examine the effects of intranasal oxytocin on physiological/cognitive
      markers of negative symptoms in 24 participants with schizophrenia spectrum traits. Subjects
      will be tested in two one-day studies carried out at least a month apart. Subjects will
      receive a 24 IU dose of intranasal oxytocin (or placebo) followed by a battery of
      cognitive/neurophysiological tests administered 50 minutes later completed over the next 155
      minutes. A second dose of the drug (oxytocin or placebo) will be administered 2 hours after
      the 1st in order to maintain therapeutic plasma levels and to complete all testing.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 24 IU oxytocin (or Placebo) in a total of 6 puffs (3 puffs per nostril); Single dose (plus a booster dose) drug probe study using intranasal placebo
Other intervention name(s): Pitocin; Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Schizophrenia; Eye movements; phenotype; biochemical; relatives