Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02149823
Recruitment Status : Recruiting
First Posted : May 29, 2014
Last Update Posted : November 16, 2018
Sponsor:
Collaborators:
James J. Peters Veterans Affairs Medical Center
VISN 3 Mental Illness Research, Education and Clinical Center
Information provided by (Responsible Party):
Maria de las Mercedes Perez Rodriguez, Icahn School of Medicine at Mount Sinai

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
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

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 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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Intranasal Oxytocin Group 1
Placebo on visit 1, oxytocin 24IU on visit 2, then 40 IU on visit 3
 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
 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.
 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
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. Movie for the Assessment of Social Cognition (MASC) [ Time Frame: Day 29 ]
  3. Movie for the Assessment of Social Cognition (MASC) [ Time Frame: Day 57 ]

Secondary Outcome Measures :
  1. 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.

  2. Reading of the Mind in the Eyes [ Time Frame: Day 29 ]
  3. Reading of the Mind in the Eyes [ Time Frame: Day 57 ]
  4. 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)

  5. Resting-state functional connectivity [ Time Frame: Day 29 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Sarah B Rutter, MA 212-241-2190 Sarah.Rutter@mssm.edu

Locations
Layout table for location information
United States, New York
James J Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Harold Koenigsberg, MD    718-584-9000 ext 5227    harold.koenigsberg@mssm.edu   
Principal Investigator: Harold Koenigsberg, MD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Maria de las Mercedes Perez Rodriguez, MD, PhD    212-659-8738    Mercedes.Perez@Mssm.edu   
Principal Investigator: Maria de las Mercedes Perez Rodriguez, MD, PhD         
Sponsors and Collaborators
Maria de las Mercedes Perez Rodriguez
James J. Peters Veterans Affairs Medical Center
VISN 3 Mental Illness Research, Education and Clinical Center
Investigators
Layout table for investigator information
Principal Investigator: Maria de las Mercedes Perez Rodriguez, MD, PhD Icahn School of Medicine at Mount Sinai; James J. Peters VA Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Maria de las Mercedes Perez Rodriguez, Fellow, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02149823     History of Changes
Other Study ID Numbers: GCO 13-0340
UL1TR000067 ( U.S. NIH Grant/Contract )
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Keywords provided by Maria de las Mercedes Perez Rodriguez, Icahn School of Medicine at Mount Sinai:
Oxytocin, Social Cognition
Borderline Personality Disorder
Schizotypal Personality Disorder
Social Cognition
BPD
SPD
 MASC
Autism Spectrum Disorder
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
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