Study Stopped
All study proceedings stopped prematurely due to Covid-19 restrictions for intranasal formulations
Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
2 other identifiers
interventional
92
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2013
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2022
CompletedOctober 10, 2022
October 1, 2022
6.8 years
May 21, 2014
October 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Movie for the Assessment of Social Cognition (MASC)
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.
Day 1
Movie for the Assessment of Social Cognition (MASC)
Day 29
Movie for the Assessment of Social Cognition (MASC)
Day 57
Secondary Outcomes (5)
Reading of the Mind in the Eyes
Day 1
Reading of the Mind in the Eyes
Day 29
Reading of the Mind in the Eyes
Day 57
Resting-state functional connectivity
Day 1
Resting-state functional connectivity
Day 29
Study Arms (5)
Intranasal Oxytocin Group 1
ACTIVE COMPARATORPlacebo on visit 1, oxytocin 24IU on visit 2, then 40 IU on visit 3
Intranasal Oxytocin Group 2
ACTIVE COMPARATORoxytocin 24IU on visit 1, placebo on visit 2, then oxytocin 40IU on visit 3
Intranasal Oxytocin Group 3
ACTIVE COMPARATORoxytocin 40IU on visit 1, oxytocin 24IU on visit 2, then placebo on visit 3.
Intranasal Oxytocin Group 4
ACTIVE COMPARATORafter visit 4, placebo on subsequent visit , then oxytocin 40IU at following visit
Intranasal Oxytocin Group 5
ACTIVE COMPARATORafter visit 4, oxytocin 40IU on subsequent visit, then placebo at following visit
Interventions
Eligibility Criteria
You may qualify if:
- ≤ age ≤ 65
- Medically and neurologically healthy
- Willing and able to provide informed consent
- IQ≥80
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
James J Peters VA Medical Center
The Bronx, New York, 10468, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria de las Mercedes Perez Rodriguez, MD, PhD
Icahn School of Medicine at Mount Sinai; James J. Peters VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Fellow
Study Record Dates
First Submitted
May 21, 2014
First Posted
May 29, 2014
Study Start
September 1, 2013
Primary Completion
July 1, 2020
Study Completion
June 14, 2022
Last Updated
October 10, 2022
Record last verified: 2022-10