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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia?

NCTNCT01312272 (opens ClinicalTrials.gov in a new tab)Other idPCC 2011-020223
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
24 participants (actual)
Sponsor
VA Greater Los Angeles Healthcare System · Fed
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Apr 2011
Primary completion
Aug 2012
Completion
Aug 2012
First posted
10 Mar 2011 (estimated)
Last update posted
2 May 2014 (estimated)
Conditions
Schizophrenia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. N/A

    Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia?

    NCT01312272

    Apr 2011 to Aug 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Individuals with schizophrenia have been found to have deficits in social cognition, which is defined as the functions that are engaged during social interactions. Social cognition has been found to be critical in predicting multiple aspects of community functioning. There are no currently available medications that have been consistently found to improve social cognition in individuals with schizophrenia. Oxytocin functions as a neurotransmitter that is thought to be involved in multiple aspects of social behavior and related emotions. In this study, we test the hypothesis that acute administration of intranasal oxytocin will improve social cognition in individuals with schizophrenia.

Interventions

  • OxytocinDrug
  • Inactive placebo nasal sprayDrug

Arms2

  • Placebo comparator

    Inactive nasal spray

    A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.

  • Experimental

    Intranasal Oxytocin

    Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Social Cognition Composite Measure

    Time frame · Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

    Registry description

    Our primary outcome measure will be a composite score created by calculating the mean of the four main social cognition measures assessed in this study (two "high-level" measures and two "low-level" measures). Because these measures are not on the same scale, we will first z-score (center and scale) each of the four measures at each time point using the baseline mean and standard deviation of the whole sample and then calculate the mean of the z-scores to create the composite social cognition score.

Secondary outcomes(5)

  1. Theory of Mind Assessment (High Level Social Cognition)

    Time frame · Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

    Registry description

    The Awareness of Social Inference Test (TASIT Part III: Social Inference - Enriched) will be administered to assess theory of mind.

  2. Empathy

    Time frame · Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

    Registry description

    Empathy was assessed using the Emotional Perspective Taking Task (EPTT) (Derntl et al., 2009). In this task, subjects are presented with 60 digital images depicting two individuals in a social interaction, with one individual's face masked. Subjects are asked to infer the emotional expression of the masked face, selecting between two choices. Scenes portray 5 basic emotions as well as neutrality and each image is displayed for 4 s each.

  3. Social Perception Assessment (Low Level Social Cognition)

    Time frame · Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

    Registry description

    We will assess social perception using the Half-Profile of Nonverbal Sensitivity (Half-PONS). Brief scenes are shown that include facial expressions, voice intonations, and/or body gestures. Subjects select a label that best describes the situation. The dependent measure is the total number of correct labels.

  4. Facial Affect Recognition (Low Level Social Cognition)

    Time frame · Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

    Registry description

    Participants are asked to identify facial expressions of emotion in still photographs from the standardized stimulus set developed by Ekman. The test includes digitized color photos of eight different posers displaying facial expressions of six basic emotions plus neutral expressions. On each trial, a photo and a list of the seven possible expressions are simultaneously presented on the screen. The participant verbally identifies the emotion he/she believes is correct and the experimenter enters the response. The dependent measure is the total number correct.

  5. Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score

    Time frame · Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

    Registry description

    This is a frequently used instrument, initially developed by Kay, Opler, and Fiszbein, that assesses 30 different symptoms (categorized into positive, negative, and general psychopathology) on a scale from 1 to 7, based on clinical interview. It will be used to compare the psychopathology between the two treatment groups. The maximum Total Score on the scale is 210 and the minimum score is 30, with higher values indicating more severe symptoms. The maximum scale of 210 is the sum of the scores from each symptom category (positive symptoms = range 7 to 49; negative symptoms = range 7 to 49; general psychopathology = range to 16 to 112). Our outcome measure refers to the change in the PANSS Total Score. A greater decrease on the scale indicates greater improvement in symptoms (e.g., a participant with a change score of -20 improved more on the PANSS than a participant with a change score of -5).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

Social Cognition Composite Measure

GroupValue (Change in z-score)Spread
Inactive Nasal Spray0.100.35
Intranasal Oxytocin0.230.36
Secondary and other outcome results(5)
Secondary outcomeMean· Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

Theory of Mind Assessment (High Level Social Cognition)

GroupValue (Change in z-score)Spread
Inactive Nasal Spray-0.010.47
Intranasal Oxytocin0.180.83
Secondary outcomeMean· Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

Empathy

GroupValue (Change in z-score)Spread
Inactive Nasal Spray0.240.63
Intranasal Oxytocin0.610.76
Secondary outcomeMean· Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

Social Perception Assessment (Low Level Social Cognition)

GroupValue (Change in z-score)Spread
Inactive Nasal Spray0.150.77
Intranasal Oxytocin00.73
Secondary outcomeMean· Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

Facial Affect Recognition (Low Level Social Cognition)

GroupValue (Change in z-score)Spread
Inactive Nasal Spray0.050.67
Intranasal Oxytocin0.220.45
Secondary outcomeMean· Visit 2 (baseline), Visit 3 (1 week following, post-treatment)

Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score

GroupValue (change in units on scale)Spread
Inactive Nasal Spray-10.835.37
Intranasal Oxytocin-8.896.19

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Inactive Nasal SprayA placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water. Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.–0 / 122 / 12
Intranasal OxytocinOxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml. Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time–0 / 112 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies9

Studies that cite this trial.

Studies with results

7 studies on this page

Indexing hint: Randomized controlled trial · 2013

2 results

Effects of single dose intranasal oxytocin on social cognition in schizophrenia.

Davis et al. 2013Schizophrenia researchcited by 95

PMID 23676253DOI 10.1016/j.schres.2013.04.023PUB-23676253

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2010

4 results

Adjunctive intranasal oxytocin reduces symptoms in schizophrenia patients.

Feifel et al. 2010Biological psychiatrycited by 243

PMID 20615494DOI 10.1016/j.biopsych.2010.04.039PUB-20615494

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2009

4 results

Intranasal administration of oxytocin increases envy and schadenfreude (gloating).

Shamay-Tsoory et al. 2009Biological psychiatrycited by 326

PMID 19640508DOI 10.1016/j.biopsych.2009.06.009PUB-19640508

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2008

2 results

Oxytocin increases gaze to the eye region of human faces.

Guastella et al. 2008Biological psychiatrycited by 538

PMID 17888410DOI 10.1016/j.biopsych.2007.06.026PUB-17888410

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Observational study · 2008

6 results

Diminished plasma oxytocin in schizophrenic patients with neuroendocrine dysfunction and emotional deficits.

Goldman et al. 2008Schizophrenia researchcited by 159

PMID 17961988PMC2277481DOI 10.1016/j.schres.2007.09.019PUB-17961988

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Randomized controlled trial · 2007

2 results

Oxytocin improves "mind-reading" in humans.

Domes et al. 2007Biological psychiatrycited by 826

PMID 17137561DOI 10.1016/j.biopsych.2006.07.015PUB-17137561

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Clinical trial · 2005

3 results

Oxytocin increases trust in humans.

Kosfeld et al. 2005Naturecited by 1,701

PMID 15931222DOI 10.1038/nature03701PUB-15931222

Full text at the publisher3 results
Publisher pageSee results (3)

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2010

Oxytocin selectively improves empathic accuracy.

Bartz et al. 2010Psychological sciencecited by 281

PMID 20855907PMC6634294DOI 10.1177/0956797610383439PUB-20855907

Rights unknown
Source link

PubMed tag: none · 2009

Sharing secrets: oxytocin and trust in schizophrenia.

Kéri et al. 2009Social neurosciencecited by 120

PMID 18671168DOI 10.1080/17470910802319710PUB-18671168

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Veteran being treated in the Veterans Administration Healthcare System * Meet DSM-IV-TR criteria for Schizophrenia * At least 6 months since any hospitalization or substantial increase in level of care for an acute exacerbation of psychotic symptoms * At least 1 month since meeting the criteria for having a major depressive episode * At least 6 months since any behaviors suggesting any potential danger to self or others * Adherence to the regular administration of an antipsychotic medication (e.g., risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, paliperidone, iloperidone, asenapine, fluphenazine, haloperidol, loxapine, molindone, perphenazine, thiothixene, chlorpromazine, clozapine) * Dose of antipsychotic medication not varying by more than 25% over the 3 months prior to study participation * No acute medical problems * Chronic medical conditions (e.g., hypertension, diabetes, dyslipidemia) consistently treated and stable for at least 3 months prior to study participation * Ability to provide signed informed consent and to cooperate with study procedures Exclusion Criteria: * Documented history of mental retardation or severe learning disability * History of treatment with electroconvulsive therapy within 6 months prior to study participation * History of neurological or neuropsychiatric condition (e.g., stroke, severe traumatic brain injury, epilepsy, etc.) * Documented history of persistent substance abuse or dependence within 6 months prior to study participation * History of hyponatremia within the past 6 months * Allergic rhinitis or other inflammation of the nasal mucosa

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