NCT01394471

Brief Summary

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, psychotic symptoms and social functioning in schizophrenia. Participants: 80 adults with schizophrenia or schizoaffective disorder for at least one year. Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray for 12 weeks. Before, during and at the end of the trial, each subject will undergo psychiatric symptom ratings and tests of mental abilities used in social functioning, cognition, and social competence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 11, 2015

Status Verified

June 1, 2015

Enrollment Period

3.5 years

First QC Date

July 11, 2011

Last Update Submit

June 9, 2015

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

schizophreniaschizoaffective disorderoxytocinOTsocial cognitionsocial functioningparanoiapsychosispsychotic symptomssocial deficitsintranasal administration

Outcome Measures

Primary Outcomes (1)

  • Change in social cognition scores from baseline to 6 and 12 week time points

    Baseline, Week 6, and Week 12 visits

Secondary Outcomes (2)

  • Change in social functioning measures from baseline to 6 and 12 week time points

    Baseline, Week 6, and Week 12 visits

  • Change in PANSS total and subscale scores from baseline to 6 and 12 week time points.

    Baseline, Week 6 and Week 12 visits

Study Arms (2)

oxytocin

EXPERIMENTAL

Twice daily treatment of oxytocin will be administered by subjects

Drug: Intranasal Oxytocin Spray

Control spray

PLACEBO COMPARATOR

Self administration twice daily of intranasal spray that does not contain oxytocin

Drug: Intranasal Oxytocin Spray

Interventions

Intranasal Oxytocin SprayDRUG

6 insufflations (24IU of oxytocin total) given twice daily for 12 weeks

Also known as: Syntocinon spray
Control sprayoxytocin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs of age;
  • currently meeting DSM-IV criteria for schizophrenia or schizoaffective disorder with onset occurring \> 1 year prior to enrollment in the study;
  • score of \<24 on the Reading the Mind in the Eyes Test ("Eyes Test", Baron-Cohen, et al 2001), which represents 0.5 SD below the mean in a large normative sample OR
  • get a minimum score of "3" on at least two of the following "social" items on the PANSS ratings: suspiciousness/persecution (ideation), hostility, passive/apathetic social withdrawal, uncooperativeness, active social avoidance,
  • stable symptoms as well as being on the same medication and psychosocial therapy regimen for \> 1 month.

You may not qualify if:

  • current or lifetime history of schizoaffective (bipolar type), delusional, other psychotic (shared, substance-induced, due to a medical disorder) disorders, bipolar, cyclothymic, somatoform, dissociative, eating or personality disorders, unipolar major depressive episodes with psychotic features, dementia;
  • history of mania or hypomania within the past two years
  • substance use or abuse disorder during the past 3 months (except tobacco, caffeine);
  • treatment currently or within the past 6 months with high dose sedative-hypnotics, stimulants, chronic glucocorticoids (other medications that are adequately controlling acute or chronic disorders \[e.g., hypertension, diabetes, hypo or hyperthyroidism, asthma, allergies, mild infections etc.\] are allowed);
  • major surgery/trauma in the past 4 months;
  • pregnancy, childbirth or breast-feeding in the past year;
  • significant physical exam, laboratory or EKG abnormalities;
  • reading level \< 5th grade on the Wide Range Achievement Test (WRAT, Wilkinson 1993);
  • inability to read English well enough to complete study questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (15)

  • Kohler CG, Turner TH, Gur RE, Gur RC. Recognition of facial emotions in neuropsychiatric disorders. CNS Spectr. 2004 Apr;9(4):267-74. doi: 10.1017/s1092852900009202.

    PMID: 15048051BACKGROUND

  • Brüne M (2003) Social cognition and behaviour in schizophrenia. In Brüne M, Ribbert H, Schiefenhövel W (eds.) The social brain-evolution and pathology. John Wiley & Sons; Chichester, pp. 277-313.

    BACKGROUND

  • Baron-Cohen S, Wheelwright S, Hill J, Raste Y, Plumb I. The "Reading the Mind in the Eyes" Test revised version: a study with normal adults, and adults with Asperger syndrome or high-functioning autism. J Child Psychol Psychiatry. 2001 Feb;42(2):241-51.

    PMID: 11280420BACKGROUND

  • Adolphs R, Tranel D, Damasio AR. The human amygdala in social judgment. Nature. 1998 Jun 4;393(6684):470-4. doi: 10.1038/30982.

    PMID: 9624002BACKGROUND

  • Combs DR, Penn DL, Wicher M, Waldheter E. The Ambiguous Intentions Hostility Questionnaire (AIHQ): a new measure for evaluating hostile social-cognitive biases in paranoia. Cogn Neuropsychiatry. 2007 Mar;12(2):128-43. doi: 10.1080/13546800600787854.

    PMID: 17453895BACKGROUND

  • Schneider LC, Struening EL. SLOF: a behavioral rating scale for assessing the mentally ill. Soc Work Res Abstr. 1983 Fall;19(3):9-21. doi: 10.1093/swra/19.3.9.

    PMID: 10264257BACKGROUND

  • Pinkham AE, Penn DL. Neurocognitive and social cognitive predictors of interpersonal skill in schizophrenia. Psychiatry Res. 2006 Aug 30;143(2-3):167-78. doi: 10.1016/j.psychres.2005.09.005. Epub 2006 Jul 21.

    PMID: 16859754BACKGROUND

  • Williams KD, Cheung CK, Choi W. Cyberostracism: effects of being ignored over the Internet. J Pers Soc Psychol. 2000 Nov;79(5):748-62. doi: 10.1037//0022-3514.79.5.748.

    PMID: 11079239BACKGROUND

  • Davis, MH (1983) Measuring individual differences in empathy: Evidence for a multidimensional approach. J Personal Soc Psychol 44:113-126.

    BACKGROUND

  • Randolph, C. (1998). Repeatable Battery for the Assessment of Neuropsychological Status Manual. San Antonio, TX: Psychological Corporation.

    BACKGROUND

  • Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

    PMID: 3616518BACKGROUND

  • Green CE, Freeman D, Kuipers E, Bebbington P, Fowler D, Dunn G, Garety PA. Measuring ideas of persecution and social reference: the Green et al. Paranoid Thought Scales (GPTS). Psychol Med. 2008 Jan;38(1):101-11. doi: 10.1017/S0033291707001638. Epub 2007 Oct 1.

    PMID: 17903336BACKGROUND

  • Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: the Calgary Depression Scale. Br J Psychiatry Suppl. 1993 Dec;(22):39-44.

    PMID: 8110442BACKGROUND

  • Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.

    PMID: 2885745BACKGROUND

  • Merritt CC, Halverson TF, Elliott T, Jarskog LF, Pedersen CA, Penn DL. Racial disparities and predictors of functioning in schizophrenia. Am J Orthopsychiatry. 2023;93(3):177-187. doi: 10.1037/ort0000661. Epub 2023 Mar 16.

    PMID: 36931838DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSocial AdjustmentParanoid Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Cort A Pedersen, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • David L Penn, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 14, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations

US(1)