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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 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) in borderline personality disorder (BPD) and schizotypal personality disorder (SPD) 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 Summary:

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 and personality disorders. Individuals with schizotypal personality disorder 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. The investigators 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, the aim is 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, the investigators propose to perform a 2-year study in which 30 patients, (15 schizotypal, 15 borderline) 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. 15 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 practi
Sponsor: Maria de las Mercedes Perez Rodriguez

Current Primary Outcome:

• 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: Same as current

Current Secondary Outcome:

• 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:

• 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 ]

Dates:
Date Received: May 21, 2014
Date Started: September 2013
Date Completion: August 2018
Last Updated: August 4, 2016
Last Verified: August 2016