Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
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ClinicalTrials.gov Identifier: NCT02149823 |
Recruitment Status :
Suspended
(All study proceedings are currently paused due to Covid-19 restrictions)
First Posted : May 29, 2014
Last Update Posted : October 21, 2021
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Condition or disease | Intervention/treatment | Phase |
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Borderline Personality Disorder BPD Schizotypal Personality Disorder SPD Autism Spectrum Disorder Schizophrenia Schizoaffective Disorder Bipolar Disorder | Drug: Syntocinon 24 Intranasal Units (IU) Drug: Syntocinon 40 Intranasal Units (IU) Drug: Intranasal Placebo | Phase 1 |
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 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 practice effects. Social cognitive testing will be performed 45 minutes after drug/placebo 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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 165 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations |
Study Start Date : | September 2013 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | July 2022 |

Arm | Intervention/treatment |
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Active Comparator: Intranasal Oxytocin Group 1
Placebo on visit 1, oxytocin 24IU on visit 2, then 40 IU on visit 3
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Drug: Syntocinon 24 Intranasal Units (IU)
Other Name: Intranasal Oxytocin Drug: Syntocinon 40 Intranasal Units (IU) Other Name: Intranasal Oxytocin Drug: Intranasal Placebo |
Active Comparator: Intranasal Oxytocin Group 2
oxytocin 24IU on visit 1, placebo on visit 2, then oxytocin 40IU on visit 3
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Drug: Syntocinon 24 Intranasal Units (IU)
Other Name: Intranasal Oxytocin Drug: Syntocinon 40 Intranasal Units (IU) Other Name: Intranasal Oxytocin Drug: Intranasal Placebo |
Active Comparator: Intranasal Oxytocin Group 3
oxytocin 40IU on visit 1, oxytocin 24IU on visit 2, then placebo on visit 3.
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Drug: Syntocinon 24 Intranasal Units (IU)
Other Name: Intranasal Oxytocin Drug: Syntocinon 40 Intranasal Units (IU) Other Name: Intranasal Oxytocin Drug: Intranasal Placebo |
Active Comparator: Intranasal Oxytocin Group 4
after visit 4, placebo on subsequent visit , then oxytocin 40IU at following visit
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Drug: Syntocinon 40 Intranasal Units (IU)
Other Name: Intranasal Oxytocin Drug: Intranasal Placebo |
Active Comparator: Intranasal Oxytocin Group 5
after visit 4, oxytocin 40IU on subsequent visit, then placebo at following visit
|
Drug: Syntocinon 40 Intranasal Units (IU)
Other Name: Intranasal Oxytocin Drug: Intranasal Placebo |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149823
United States, New York | |
James J Peters VA Medical Center | |
Bronx, New York, United States, 10468 | |
Icahn School of Medicine at Mount Sinai | |
New York, New York, United States, 10029 |
Principal Investigator: | Maria de las Mercedes Perez Rodriguez, MD, PhD | Icahn School of Medicine at Mount Sinai; James J. Peters VA Medical Center |
Responsible Party: | Maria de las Mercedes Perez Rodriguez, Fellow, Icahn School of Medicine at Mount Sinai |
ClinicalTrials.gov Identifier: | NCT02149823 |
Other Study ID Numbers: |
GCO 13-0340 UL1TR000067 ( U.S. NIH Grant/Contract ) |
First Posted: | May 29, 2014 Key Record Dates |
Last Update Posted: | October 21, 2021 |
Last Verified: | October 2021 |
Oxytocin, Social Cognition Borderline Personality Disorder Schizotypal Personality Disorder Social Cognition BPD SPD |
MASC Autism Spectrum Disorder Schizophrenia Schizoaffective Disorder Bipolar Disorder |
Disease Schizophrenia Bipolar Disorder Autism Spectrum Disorder Psychotic Disorders Personality Disorders Borderline Personality Disorder Schizotypal Personality Disorder Pathologic Processes |
Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Bipolar and Related Disorders Child Development Disorders, Pervasive Neurodevelopmental Disorders Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |