Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02149823
Status:
TERMINATED
Last Update Posted:
2022-10-10
First Post:
2014-05-21
Brief Title:
Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
Sponsor:
Maria de las Mercedes Perez Rodriguez
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
All study proceedings stopped prematurely due to Covid-19 restrictions for intranasal formulations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 oxytocinplacebo 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 drugplacebo 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
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 oxytocinplacebo 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 drugplacebo 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1TR000067 | NIH | None | httpsreporternihgovquickSearchUL1TR000067 |