TerminatedPhase 1

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

Stopped: All study proceedings stopped prematurely due to Covid-19 restrictions for intranasal formulations

United States92 participantsStarted 2013-09

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Movie for the Assessment of Social Cognition (MASC)

Timeframe: Day 1

Movie for the Assessment of Social Cognition (MASC)

Timeframe: Day 29

Movie for the Assessment of Social Cognition (MASC)

Timeframe: Day 57

Trial details

NCT IDNCT02149823

SponsorMaria de las Mercedes Perez Rodriguez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07

View on ClinicalTrials.gov More Borderline Personality Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.