Clinical Trial: Oxytocin Treatment of Schizophrenia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Oxytocin Treatment of Social Deficits and Paranoia in Schizophrenia

Brief Summary:

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, social functioning and decreases paranoia and other psychotic symptoms in schizophrenia.

Participants: Up to 80 adults with schizophrenia for at least one year and with a high rating for paranoia.

Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray (6 insufflations/dose or 24 IU) for 6 weeks. Before, during and at the end of the trial, each subject will undergo social cognitive measures (primary outcomes) and psychiatric symptom ratings (secondary outcomes).

Detailed Summary:

Inclusion criteria: meeting Diagnostic and Statistical Manual IV (DSM-IV) criteria for paranoid or undifferentiated schizophrenia for at least 1 year; scoring > 4 on the suspiciousness/persecution (hereafter referred to as paranoia) subscale of the Positive and Negative Symptom Scale (PANSS) or 3 on the paranoia subscale and > 3 on the hostility, active social avoidance, passive/apathetic social withdrawal or uncooperativeness subscale and > 60 on the full PANSS: stability of symptom severity and on the same medication(s) and dose(s) for at least 1 month; low to moderate depressive symptoms.

Exclusion criteria: low literacy as indicated by an inability to read and understand the consent form; dependence on substances other than tobacco or caffeine; positive urine drug screen for illegal substances or drugs that have not been prescribed; debilitating medical conditions (including AIDS; HIV infection alone will not be grounds for exclusion); major surgery or trauma in the past year will be grounds for exclusion although subjects determined to be recovered and stable may be included at the discretion of the Principal Investigator (PI); pregnancy, breast-feeding; having given birth in the past 6 months or breast-feeding in the past 3 months. Individuals judged unable to learn self-administration of intranasal treatments and/or not sufficiently reliable to do so will be excluded. Abnormalities found during medical evaluation will be grounds for exclusion (see details below) although subjects with laboratory measures somewhat out of the normal range may be included at the discretion of Drs. Pedersen, Gilmore, Rau and/or Salimi.

Study Design: Randomized, double-blind, placebo-controlled design. Up to 80 subjects will complete the protocol: 40 will receive oxytocin; 40 placebo. Prior to the treatment trial, baseline measu
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome:

• Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point [ Time Frame: 6 weeks ]

  The Emotion Recognition-40 (ER-40; Kohler, Turner, Gur, & Gur, 2004) consists of a series of 40 faces, shown one at a time on a computer screen. Participants choose the correct emotions based on 5 answer choices: happy, sad, anger, fear and no emotion. Participants indicate the word that best describes the emotion each faces expresses. The stimuli are presented in a randomized order each time they are administered. A scoring program automatically records accuracy and median response time. Range for each emotion (score range) is 0 (no correct responses) to 8 (all faces on each emotion category are correctly identified).

  The ER-40 faces were derived from the University of Pennsylvania Emotion Recognition Task, 96 faces version, and are balanced for equality and intensity of emotion, age, gender and ethnicity.

• Theory of Mind as Measured by the Eyes Test at 6 Weeks [ Time Frame: 6 weeks ]
  The Eyes Test (Baron-Cohen, Wheelwright, Hill, Raste, & Plumb, 2001) consists of 36 photographs where participants are asked to guess the mental state (i.e., what the person is thinking or feeling) from among four choice words. Participants are given a practice item to ensure that they understand the task. Each eye region is displayed on a computer screen with the four choice mental states shown in the four corners of the computer screen (one target word and three foil words). The score range is 0 (no correct responses) to 36 (all stimuli are correctly identified).
• Theory of Mind as Measured by
  
  

  Original Primary Outcome: PANSS total and subscores [ Time Frame: 6 week trial ]
  
  

  Current Secondary Outcome: Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks [ Time Frame: 6 weeks ]

  The PANSS consists of 30 items (7 positive psychotic symptoms, 7 negative psychotic symptoms, 16 general psychopathology symptoms) on which subjects are rated (1-7) based upon a semi-standardized interview. Higher scores indicate more/greater symptoms (i.e., greater symptoms of psychosis) and lower scores indicate fewer symptoms (better outcome).

  Possible score range: min, max Total: 30,210 Positive symptoms:7, 49 Negative symptoms:7, 49 General symptoms: 16,112

  
  
  

  Original Secondary Outcome: Social cognition and skill tasks [ Time Frame: 6 week trial ]
  
  Information By: University of North Carolina, Chapel Hill
  

  Dates:
  Date Received: December 4, 2009
  Date Started: November 2009
  Date Completion:
  Last Updated: March 6, 2017
  Last Verified: March 2017