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Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations

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ClinicalTrials.gov Identifier: NCT02149823
Recruitment Status : Recruiting
First Posted : May 29, 2014
Last Update Posted : November 16, 2018
Sponsor:
Collaborators:
James J. Peters Veterans Affairs Medical Center
VISN 3 Mental Illness Research, Education and Clinical Center
Information provided by (Responsible Party):
Maria de las Mercedes Perez Rodriguez, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE May 21, 2014
First Posted Date  ICMJE May 29, 2014
Last Update Posted Date November 16, 2018
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2014)
  • Movie for the Assessment of Social Cognition (MASC) [ Time Frame: Day 1 ]
    The MASC involves watching a 15 min movie about 4 characters getting together for a dinner party. The video is paused 45 times and questions concerning the characters' feelings, thoughts, and intentions are asked. It takes 40 min to complete. The multiple choice version of the MASC allows a qualitative social cognition error analysis.
  • Movie for the Assessment of Social Cognition (MASC) [ Time Frame: Day 29 ]
  • Movie for the Assessment of Social Cognition (MASC) [ Time Frame: Day 57 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02149823 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
  • Reading of the Mind in the Eyes [ Time Frame: Day 1 ]
    The 'Reading the Mind in the Eyes' (Eyes) test is an advanced test of theory of mind. It is widely used to assess individual differences in social cognition and emotion recognition across different groups and cultures. The social cognition measure will be administered as a control task.
  • Reading of the Mind in the Eyes [ Time Frame: Day 29 ]
  • Reading of the Mind in the Eyes [ Time Frame: Day 57 ]
  • Resting-state functional connectivity [ Time Frame: Day 1 ]
    Participants will undergo resting-state functional MRI scanning while viewing a fixation cross on a black screen, with instructions to lie still and keep their eyes open. A non-invasive eye-tracking device (available as an MRI peripheral) will be used to ensure that participants do not fall asleep during the long resting-state period, and to track eye gaze during the social cognition task. Resting-state scanning will be done during the onset of oxytocin effects until peak effects are achieved (approximately 30 minutes post administration)
  • Resting-state functional connectivity [ Time Frame: Day 29 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2014)
  • Reading of the Mind in the Eyes [ Time Frame: Day 1 ]
    The 'Reading the Mind in the Eyes' (Eyes) test is an advanced test of theory of mind. It is widely used to assess individual differences in social cognition and emotion recognition across different groups and cultures. The social cognition measure will be administered as a control task.
  • Reading of the Mind in the Eyes [ Time Frame: Day 29 ]
  • Reading of the Mind in the Eyes [ Time Frame: Day 57 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
Official Title  ICMJE Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
Brief Summary Social cognition impairment is critical to the pathology and morbidity of a number of psychiatric disorders, including the schizophrenia spectrum, the autism spectrum and the personality disorders, thus representing a dimension consistent with RDoC. As such, this study aims to a) further characterize the unique deficits in social cognition (recognition and interpretation of social cues and representation of thoughts, intentions, and feelings of others) across disorders, including the schizophrenia spectrum (which includes schizophrenia, SCZ, schizoaffective disorder, SAD, bipolar disorder, BD, and schizotypal personality disorder, SPD), the autism spectrum disorders (ASD), and borderline personality disorder (BPD) compared to healthy controls (HC); b) assess the effect of intranasal oxytocin (OXT) as a regulator and novel treatment of social cognition impairment in these disorders; and c) enhance our understanding of the specificity and exact mechanisms of impairment to inform the accurate dosing of OXT required to modulate social cognition in these disorders and identify a model of optimum social cognitive function. Addressing these questions will further catalyze research into a model of optimum social cognitive activity, and accelerate industry development of agents suited to routine clinical administration.
Detailed Description

Social cognitive impairments, particularly deficits and distortions in recognition and interpretation of social cues and representations of thoughts, intentions, and feelings of others—termed mentalization—are a key contributor to the pathology and morbidity of a number of psychiatric disorders, including the schizophrenia spectrum, the autism spectrum and personality disorders. Individuals with schizophrenia spectrum disorders have deficits in social cognition (hypomentalization), while individuals with borderline personality disorder seem to have exaggerated and distorted social cognition (hypermentalization). However, the specificity and mechanisms of these impairments remain unclear. Therefore, a better understanding of the modulation of social cognition is a priority for developing interventions both pharmacologic and psychosocial. We propose here to examine the effects of oxytocin, known to be a key regulator of social cognition through modulating frontolimbic neural circuitry, on social cognition in schizotypal and borderline patients. In doing so, we aim to characterize a model of optimum social cognitive activity to direct the development of treatments, including dosing and target population-specific effects.

To this end, we propose to perform a 2-year study in which 105 patients, (45 with schizophrenia spectrum disorders, 30 with borderline personality disorder, and 30 with autism spectrum disorders) will perform 3 rounds of social cognition testing after three acute single-dose treatment conditions (intranasal oxytocin dose of 24IU or 40IU or placebo) separated by a washout period, in a repeated-measures, within-subjects, randomized, placebo-controlled, double-blind, counterbalanced cross-over proof-of concept design. 30 healthy controls will not receive oxytocin/placebo and will perform 3 rounds of social cognition tests separated by approximately 4 weeks, serving as a benchmark for normal performance and a control for practice effects. Social cognitive testing will be performed 45 minutes after drug/placebo administration in an identical protocol each time. The social cognitive test serving as primary outcome measure will be the Movie for the Assessment of Social Cognition (MASC). We will also include other tests of social cognition and symptom measures, to evaluate scope of effects. We will compare outcome measures at baseline (placebo day) in schizotypal and borderline patients and healthy controls, and in schizotypal and borderline patients across drug doses and placebo administration.

Furthermore, 60 subjects (15 HC, 15 with schizophrenia spectrum disorders, 15 BPD, and 15 with autism spectrum disorders, either new subjects or already enrolled subjects) will be expected to complete an add-on MRI component of the study, after signing an additional consent form. For the MRI portion of the study, these subjects will perform 2 more rounds of social cognition testing after receiving double-blind intranasal oxytocin (40 IU) or placebo in randomized order, in a cross-over, within-subjects design, separated by approximately a 1-week washout. The subjects will receive the study medication directly prior to beginning an fMRI scan that will last approximately two hours. Oxytocin levels will be measured before oxytocin administration and every 10-15 minutes until about 2 hours and 30 minutes post-administration. The remainder of the protocol will remain the same.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Borderline Personality Disorder
  • BPD
  • Schizotypal Personality Disorder
  • SPD
  • Autism Spectrum Disorder
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
Intervention  ICMJE
  • Drug: Syntocinon 24 Intranasal Units (IU)
    Other Name: Intranasal Oxytocin
  • Drug: Syntocinon 40 Intranasal Units (IU)
    Other Name: Intranasal Oxytocin
  • Drug: Intranasal Placebo
Study Arms  ICMJE
  • Active Comparator: Intranasal Oxytocin Group 1
    Placebo on visit 1, oxytocin 24IU on visit 2, then 40 IU on visit 3
    Interventions:
    • Drug: Syntocinon 24 Intranasal Units (IU)
    • Drug: Syntocinon 40 Intranasal Units (IU)
    • Drug: Intranasal Placebo
  • Active Comparator: Intranasal Oxytocin Group 2
    oxytocin 24IU on visit 1, placebo on visit 2, then oxytocin 40IU on visit 3
    Interventions:
    • Drug: Syntocinon 24 Intranasal Units (IU)
    • Drug: Syntocinon 40 Intranasal Units (IU)
    • Drug: Intranasal Placebo
  • Active Comparator: Intranasal Oxytocin Group 3
    oxytocin 40IU on visit 1, oxytocin 24IU on visit 2, then placebo on visit 3.
    Interventions:
    • Drug: Syntocinon 24 Intranasal Units (IU)
    • Drug: Syntocinon 40 Intranasal Units (IU)
    • Drug: Intranasal Placebo
  • Active Comparator: Intranasal Oxytocin Group 4
    after visit 4, placebo on subsequent visit , then oxytocin 40IU at following visit
    Interventions:
    • Drug: Syntocinon 40 Intranasal Units (IU)
    • Drug: Intranasal Placebo
  • Active Comparator: Intranasal Oxytocin Group 5
    after visit 4, oxytocin 40IU on subsequent visit, then placebo at following visit
    Interventions:
    • Drug: Syntocinon 40 Intranasal Units (IU)
    • Drug: Intranasal Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2017)
165
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2014)
45
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 ≤ age ≤ 65
  • Medically and neurologically healthy
  • Willing and able to provide informed consent
  • IQ≥80

Exclusion Criteria:

  • Currently meets for a psychotic episode
  • Clinically significant cardiovascular or neurological conditions, traumatic brain injury, uncontrolled hypertension, clinically significant EKG abnormalities, or serious general medical illness
  • Clinical evidence of dehydration or significant hypotension; pregnant or lactating
  • Currently meets DSM-IV-TR criteria for MDD
  • Current substance abuse (last 6 months) or past dependence on stimulants, opioids or other potentially neurotoxic drugs
  • Currently taking psychotropic or other systemic medications
  • Non-English speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sarah B Rutter, MA 212-241-2190 Sarah.Rutter@mssm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02149823
Other Study ID Numbers  ICMJE GCO 13-0340
UL1TR000067 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria de las Mercedes Perez Rodriguez, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Maria de las Mercedes Perez Rodriguez
Collaborators  ICMJE
  • James J. Peters Veterans Affairs Medical Center
  • VISN 3 Mental Illness Research, Education and Clinical Center
Investigators  ICMJE
Principal Investigator: Maria de las Mercedes Perez Rodriguez, MD, PhD Icahn School of Medicine at Mount Sinai; James J. Peters VA Medical Center
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date November 2018

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