Who is sponsoring NCT02149823?

NCT02149823 is sponsored by Maria de las Mercedes Perez Rodriguez.

What condition does NCT02149823 study?

NCT02149823 studies Borderline Personality Disorder, BPD, Schizotypal Personality Disorder, SPD, Autism Spectrum Disorder, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder.

What drugs are being tested in NCT02149823?

Interventions: Syntocinon 24 Intranasal Units (IU), Syntocinon 40 Intranasal Units (IU), Intranasal Placebo.

What is the status of NCT02149823?

NCT02149823 is currently TERMINATED.

Last reviewed 2022-10-06 · How we verify

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

NCT02149823 Phase 1 TERMINATED

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.

Details

Lead sponsor	Maria de las Mercedes Perez Rodriguez
Phase	Phase 1
Status	TERMINATED
Enrolment	92
Start date	2013-09
Completion	2022-06-14

Conditions

Borderline Personality Disorder
BPD
Schizotypal Personality Disorder
SPD
Autism Spectrum Disorder
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder

Interventions

Syntocinon 24 Intranasal Units (IU)
Syntocinon 40 Intranasal Units (IU)
Intranasal Placebo

Primary outcomes

Movie for the Assessment of Social Cognition (MASC) — 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) — Day 29
Movie for the Assessment of Social Cognition (MASC) — Day 57

Countries

United States