Oxytocin and Social Cognition in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT00884897
First received: April 20, 2009
Last updated: April 2, 2013
Last verified: April 2013

April 20, 2009
April 2, 2013
January 2010
January 2012   (final data collection date for primary outcome measure)
To determine whether exogenous OT enhances emotional intelligence and improves performance on measures of social cognition for Schizophrenia or Schizoaffective patients [ Time Frame: participants are assessed weekly for 4 weeks ] [ Designated as safety issue: No ]
  • To determine whether exogenous OT enhances emotional intelligence and improves performance on measures of social cognition for Schizophrenia or Schizoaffective patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To determine whether OT improves measures of social function, well-being and social anxiety. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To determine the relationship between aspects of social cognition and functional outcome measures as a function of OT administration. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Determine relationship between baseline serum OT levels and baseline measures of social cognition and emotional intelligence. To determine whether repeated administration of OT changes endogenous plasma levels after repeated administration [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00884897 on ClinicalTrials.gov Archive Site
  • To determine whether OT improves measures of social function, well-being and social anxiety. [ Time Frame: participants are assessed weekly for 4 weeks ] [ Designated as safety issue: No ]
  • To determine the relationship between aspects of social cognition and functional outcome measures as a function of OT administration [ Time Frame: participants are assessed weekly for 4 weeks ] [ Designated as safety issue: No ]
  • Determine relationship between baseline serum OT levels and baseline measures of social cognition and emotional intelligence [ Time Frame: participants are assessed weekly for 4 weeks ] [ Designated as safety issue: No ]
  • To determine whether repeated administration of OT changes endogenous plasma levels after repeated administration [ Time Frame: participants are assessed weekly for 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Oxytocin and Social Cognition in Schizophrenia
Oxytocin and Social Cognition in Schizophrenia

Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in patients with schizophrenia and these are not remediated by antipsychotic medications or psychosocial interventions. Social cognition is associated with functional outcome, an important step in striving for recovery in this population. The hormone and neurotransmitter, oxytocin, which has been associated with social bonding and trust has been shown to improve measures of some aspects of social cognition in humans. The study will assess the effect of acute administration of intranasal oxytocin on measures of social cognition and functioning as well as on emotional intelligence and symptoms.

Study population: The study population will include patients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6 weeks. We will enroll a total of 30 subjects (N=15 placebo and N=15 oxytocin groups).

Experimental design and methods: After a one week lead in phase, participants will undergo 3 weeks of oxytocin (20 IU BID) or placebo administration (double blind) in addition to their existing medication regimen. Outcome measures will be administered during the lead in phase, and at the end of the study drug administration phase (under the acute effect of OT). The primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Maryland Assessment of Social Competence (MASC). Secondary measures include rating from the domains of social cognition (emotion perception, attributional style, theory of mind and social perception), symptom rating and measures of social anxiety and quality of life. Side effects and symptoms will be measured weekly.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Social Cognition
  • Social Anxiety
  • Emotional Intelligence
  • Drug: Oxytocin
    Oxytocin given as 20 IU BID
  • Drug: Placebo
    Placebo given as 20 IU BID
  • Experimental: Oxytocin
    We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Placebo
    We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
    Intervention: Drug: Placebo
Lee MR, Wehring HJ, McMahon RP, Linthicum J, Cascella N, Liu F, Bellack A, Buchanan RW, Strauss GP, Contoreggi C, Kelly DL. Effects of adjunctive intranasal oxytocin on olfactory identification and clinical symptoms in schizophrenia: results from a randomized double blind placebo controlled pilot study. Schizophr Res. 2013 Apr;145(1-3):110-5. doi: 10.1016/j.schres.2013.01.001. Epub 2013 Feb 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

All participants must:

  1. Be between age 18 and 55.
  2. Meet DSM-IV criteria for Schizophrenia or Schizoaffective Disorder.
  3. Treated with a stabilized antipsychotic regimen (i.e., have had no change in antipsychotic medication in the previous six weeks and no change in dose for the past 30 days).

Exclusion criteria:

Participants will be excluded if they have evidence of:

  1. DSM-IV criteria for substance dependence in the last 6 months or DSM-IV criteria for abuse in the past 30 days.
  2. Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires. This is defined an as a score of less than 10 on the Evaluation to Sign Consent (ESC) and judged by the treating clinician.
  3. Medical illness that in the view of the investigators would compromise participation in research.
  4. History of polydipsia and/or hyponatremia
  5. Clinically significant endocrine disorders, as judged by the PI. Abnormalities in prolactin levels and thyroid function tests associated with the use of dopamine antagonist medications will not be exclusionary.
  6. Pregnancy, planning to become pregnant, or breastfeeding. In addition, women of childbearing age are required to use an effective form of birth control for the duration of the study. Effective forms of birth control include:

    • hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones),
    • surgical sterility (tubal ligation or hysterectomy)
    • IUD
    • Diaphragm with spermicide
    • Condom with spermicide
    • Abstinence
  7. Use of any drugs (prostaglandins, vasoconstricting agents or anesthetic medications, for example) that may interact with oxytocin. Justification: Avoidance of adverse interaction with oxytocin. Assessment tool(s): Clinical interview and toxicology screen
  8. History of hypersensitivity to oxytocin or vehicle, i.e. propyl parahydroxybenzoate, methyl parahydroxybenzoate, chlorobutanol hemihydrate. Assessment tool: clinical interview
  9. Presence of or history of clinically significant allergic rhinitis as assessed by the PI, M.D., or Nurse. Justification: Inflammation of nasal mucosa could interfere with mucosal absorption of intranasally administered OT. Current rhinitis from an upper respiratory infection should be resolved prior to enrollment in study.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00884897
HP-00041024
Yes
MPRC, University of Maryland
University of Maryland
National Institute on Drug Abuse (NIDA)
Principal Investigator: Deanna L Kelly, Pharm.D, BCPP University of Maryland
Principal Investigator: Mary Lee, MD National Institute on Drug Abuse (NIDA)
University of Maryland
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP