Oxytocin Treatment of Schizophrenia

NCT01028677 | Completed Results DMC

• 1 other identifier: 07-0879
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Paranoia; Schizophrenia; Schizoaffective Disorder

Keywords

oxytocin; social cognition; social skill; social functioning; paranoia; psychotic symptoms; schizophrenia; social deficits; intranasal administration

Outcome Measures

Primary Outcomes (5)

• Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point

  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.

  6 weeks

• Theory of Mind as Measured by the Eyes Test at 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).

  6 weeks

• Theory of Mind as Measured by the Brune Test at 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.

  6 weeks

• Social Perception as Measured by the Trustworthiness Task at 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.

  6 weeks

• Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 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

  6 weeks

Secondary Outcomes (1)

• Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks

  6 weeks

Study Arms (2)

intranasal spray with oxytocin

EXPERIMENTAL

Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks

Drug: intranasal spray with oxytocin

intranasal spray without oxytocin

PLACEBO COMPARATOR

Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.

Other: nasal spray without oxytocin

Interventions

intranasal spray with oxytocin DRUG

6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks

Also known as: Syntocinon Spray

intranasal spray with oxytocin

nasal spray without oxytocin OTHER

6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks

intranasal spray without oxytocin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• UNC Department of Psychiatry
• UNC Department of Psychiatry Research

MeSH Terms

Conditions

Paranoid Disorders; Schizophrenia; Psychotic Disorders; Social Skills; Social Adjustment

Interventions

Oxytocin; Nasal Sprays

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Cort Pedersen
• Organization: UNC_ChapelHill

cort_pedersen@med.unc.edu

919 966-4447

Study Officials

• Cort A Pedersen, M.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 9, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 18, 2017
• Results First Posted: April 18, 2017

Record last verified: 2017-03

Locations

US (1)