drugset / Trial / NCT01394471
Oxytocin Treatment of Social Cognitive and Functional Deficits in Schizophrenia
Phase 1
Completed
68 enrolled
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH) · collab
RandomizedSingle-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2011-07
- Primary completion
- 2015-01
- Completion
- 2015-01
Publications
- Background 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.
- Background 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.
- Background Adolphs R, Tranel D, Damasio AR. The human amygdala in social judgment. Nature. 1998 Jun 4;393(6684):470-4. doi: 10.1038/30982.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: the Calgary Depression Scale. Br J Psychiatry Suppl. 1993 Dec;(22):39-44.
- Background Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxytocin | Peptide | 24 iu | Intranasal |