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Oxytocin Treatment of Schizophrenia (OTS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cort Pedersen, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01028677
First received: December 4, 2009
Last updated: March 6, 2017
Last verified: March 2017
  Purpose

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).


Condition Intervention
Paranoia Schizophrenia Schizoaffective Disorder Drug: intranasal spray with oxytocin Other: nasal spray without oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxytocin Treatment of Social Deficits and Paranoia in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Cort Pedersen, MD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 the Brune Test at 6 Weeks [ Time Frame: 6 weeks ]
    In The Brune Test (Brune, 2003), participants are shown a series of six sets of four cartoon pictures that illustrate interactions between two or more individuals. The cartoon cards were displayed to the participant in a predetermined scrambled order. Participants are asked to rearrange the pictures in an order that conveys a logical story. After the participant arranges the cards, the examiner ensures they are in the correct sequence. If they are not in the correct order, the examiner silently arranges them so they are in the logical sequence.The participant's interpretations of the characters' beliefs are scored as correct or incorrect (zero or one), with higher scores indicating better Theory of Mind. The sum of correct answers is the outcome of interest. The participants can receive a maximum total of 23 points for the questions.

  • Social Perception as Measured by the Trustworthiness Task at 6 Weeks [ Time Frame: 6 weeks ]
    The Trustworthiness Task (Adolphs, Tranel, & Damasio, 1998) is comprised of 42 black and white photographs of the faces of unfamiliar people. Participants are shown each picture individually (on a computer monitor) and asked to rate how much they would trust that person (e.g., with their money) on a seven-point scale, ranging from -3 (very untrustworthy) to +3 (very trustworthy). They are provided with a photograph of 0 or an average face (i.e., someone they would neither trust nor distrust) to refer to throughout the task (based on Adolphs et al.'s, 1998 norms). The total score is the sum of the trustworthiness ratings. Possible range is -126 to 126.

  • Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks [ Time Frame: 6 weeks ]

    The Interpersonal Reactivity Index (IRI; Davis, 1983) is a self-report measure of cognitive and affective empathy. The IRI consists of 28 items where participants rate how well each item describes them using a five-point scale (1 to 5). The 28 items yield four subscales: perspective taking (PT), empathic concern (EC), fantasy (F), and personal distress (PD). Higher scores indicate a greater empathic response.

    Score range for IRI: min, max Total: 28, 140 PT: 7, 35 EC: 7, 35 F: 7, 35 PD: 7, 35



Secondary Outcome Measures:
  • 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



Enrollment: 17
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intranasal spray with oxytocin
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
Drug: intranasal spray with oxytocin
6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
Other Name: Syntocinon Spray
Placebo Comparator: intranasal spray without oxytocin
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
Other: nasal spray without oxytocin
6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meeting DSM-IV criteria for paranoid or undifferentiated schizophrenia for at least 1 year.
  • Scoring > or equal to 4 on the suspiciousness/persecution (paranoia) subscale of the Positive and Negative Symptoms Scale (PANSS), a full PANSS score > or equal to 60: 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 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 although subjects with laboratory measures barely outside the normal range may be included at the discretion of the Principal Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028677

Locations
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Cort A Pedersen, M.D. University of North Carolina, Chapel Hill
  More Information

Additional Information:
Responsible Party: Cort Pedersen, MD, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01028677     History of Changes
Other Study ID Numbers: 07-0879
Study First Received: December 4, 2009
Results First Received: June 28, 2014
Last Updated: March 6, 2017

Keywords provided by Cort Pedersen, MD, University of North Carolina, Chapel Hill:
oxytocin
social cognition
social skill
social functioning
paranoia
psychotic symptoms
schizophrenia
social deficits
intranasal administration

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Paranoid Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2017