Borderline Personality DisorderPhase 1NCT02149823
Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
A Phase 1 study testing Syntocinon 24 Intranasal Units (IU) and Syntocinon 40 Intranasal Units (IU) in people with Borderline Personality Disorder and BPD, run by Maria de las Mercedes Perez Rodriguez at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder, BPD, Schizotypal Personality Disorder
- What is being tested?
- Syntocinon 24 Intranasal Units (IU) and Syntocinon 40 Intranasal Units (IU)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2013to 14 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 ≤ age ≤ 65
- Medically and neurologically healthy
- Willing and able to provide informed consent
- IQ≥80
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
James J Peters VA Medical Center
The Bronx, New York, 10468
About this study
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.
Read the 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.
- Conditions
- Borderline Personality Disorder, BPD, Schizotypal Personality Disorder, SPD, Autism Spectrum Disorder, Schizophrenia
- Being tested
- Syntocinon 24 Intranasal Units (IU), Syntocinon 40 Intranasal Units (IU), Intranasal Placebo
- Keywords
- Oxytocin, Social Cognition, Borderline Personality Disorder, Schizotypal Personality Disorder, Social Cognition, BPD, SPD, MASC, Autism Spectrum Disorder, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Medical subject headings
- Borderline Personality Disorder, Schizotypal Personality Disorder, Autism Spectrum Disorder, Schizophrenia, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntocinon 24 Intranasal Units (IU)Drug
Also called Intranasal Oxytocin
Syntocinon 40 Intranasal Units (IU)Drug
Also called Intranasal Oxytocin
Intranasal PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Oxytocin Group 1 | Active comparator | Placebo on visit 1, oxytocin 24IU on visit 2, then 40 IU on visit 3 Receives: Drug: Syntocinon 24 Intranasal Units (IU); Drug: Syntocinon 40 Intranasal Units (IU); Drug: Intranasal Placebo |
| Intranasal Oxytocin Group 2 | Active comparator | oxytocin 24IU on visit 1, placebo on visit 2, then oxytocin 40IU on visit 3 Receives: Drug: Syntocinon 24 Intranasal Units (IU); Drug: Syntocinon 40 Intranasal Units (IU); Drug: Intranasal Placebo |
| Intranasal Oxytocin Group 3 | Active comparator | oxytocin 40IU on visit 1, oxytocin 24IU on visit 2, then placebo on visit 3. Receives: Drug: Syntocinon 24 Intranasal Units (IU); Drug: Syntocinon 40 Intranasal Units (IU); Drug: Intranasal Placebo |
| Intranasal Oxytocin Group 4 | Active comparator | after visit 4, placebo on subsequent visit , then oxytocin 40IU at following visit Receives: Drug: Syntocinon 40 Intranasal Units (IU); Drug: Intranasal Placebo |
| Intranasal Oxytocin Group 5 | Active comparator | after visit 4, oxytocin 40IU on subsequent visit, then placebo at following visit Receives: Drug: Syntocinon 40 Intranasal Units (IU); Drug: Intranasal Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Movie for the Assessment of Social Cognition (MASC)
Measured: Day 29
Movie for the Assessment of Social Cognition (MASC)
Measured: Day 57
Secondary outcomes (5)
Reading of the Mind in the Eyes
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.
Measured: Day 1
Reading of the Mind in the Eyes
Measured: Day 29
Reading of the Mind in the Eyes
Measured: Day 57
Resting-state functional connectivity
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)
Measured: Day 1
Resting-state functional connectivity
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startSep 2013
- Primary completionJul 2020
- Study completion14 Jun 2022
Why it stopped: All study proceedings stopped prematurely due to Covid-19 restrictions for intranasal formulations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria de las Mercedes Perez Rodriguez
- Sponsor type
- University, hospital or other
- Collaborators
- James J. Peters Veterans Affairs Medical Center, VISN 3 Mental Illness Research, Education and Clinical Center
- Responsible party
- Sponsor-investigator, Maria de las Mercedes Perez Rodriguez, Icahn School of Medicine at Mount Sinai
- Investigators
- Maria de las Mercedes Perez Rodriguez, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai; James J. Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149823
- Sponsor's protocol ID
- GCO 13-0340
- Other IDs
- UL1TR000067
- Status last verified
- Oct 2022
- First submitted
- 21 May 2014
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
- ClinicalTrials.gov ID
- NCT02149823
- Acronym / sponsor ID
- GCO 13-0340
- Conditions
- Borderline Personality Disorder, BPD, Schizotypal Personality Disorder, SPD, Autism Spectrum Disorder, Schizophrenia
- Keywords
- Oxytocin, Social Cognition, Borderline Personality Disorder, Schizotypal Personality Disorder, Social Cognition, BPD, SPD, MASC, Autism Spectrum Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All study proceedings stopped prematurely due to Covid-19 restrictions for intranasal formulations
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Maria de las Mercedes Perez RodriguezUniversity, hospital or other
- Collaborators
- James J. Peters Veterans Affairs Medical Center, VISN 3 Mental Illness Research, Education and Clinical Center
- Study start
- Sep 2013
- Primary completion
- Jul 2020 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Intranasal Oxytocin Group 1 | Active comparator | Drug: Syntocinon 24 Intranasal Units (IU), Drug: Syntocinon 40 Intranasal Units (IU), Drug: Intranasal PlaceboPlacebo on visit 1, oxytocin 24IU on visit 2, then 40 IU on visit 3 |
| Intranasal Oxytocin Group 2 | Active comparator | Drug: Syntocinon 24 Intranasal Units (IU), Drug: Syntocinon 40 Intranasal Units (IU), Drug: Intranasal Placebooxytocin 24IU on visit 1, placebo on visit 2, then oxytocin 40IU on visit 3 |
| Intranasal Oxytocin Group 3 | Active comparator | Drug: Syntocinon 24 Intranasal Units (IU), Drug: Syntocinon 40 Intranasal Units (IU), Drug: Intranasal Placebooxytocin 40IU on visit 1, oxytocin 24IU on visit 2, then placebo on visit 3. |
| Intranasal Oxytocin Group 4 | Active comparator | Drug: Syntocinon 40 Intranasal Units (IU), Drug: Intranasal Placeboafter visit 4, placebo on subsequent visit , then oxytocin 40IU at following visit |
| Intranasal Oxytocin Group 5 | Active comparator | Drug: Syntocinon 40 Intranasal Units (IU), Drug: Intranasal Placeboafter visit 4, oxytocin 40IU on subsequent visit, then placebo at following visit |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 ≤ age ≤ 65
- Medically and neurologically healthy
- Willing and able to provide informed consent
- IQ≥80
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syntocinon 24 Intranasal Units (IU)Also: Intranasal Oxytocin | Drug | Intranasal Oxytocin Group 1, Intranasal Oxytocin Group 2, Intranasal Oxytocin Group 3 |
| Syntocinon 40 Intranasal Units (IU)Also: Intranasal Oxytocin | Drug | Intranasal Oxytocin Group 1, Intranasal Oxytocin Group 2, Intranasal Oxytocin Group 3, Intranasal Oxytocin Group 4, Intranasal Oxytocin Group 5 |
| Intranasal Placebo | Drug | Intranasal Oxytocin Group 1, Intranasal Oxytocin Group 2, Intranasal Oxytocin Group 3, Intranasal Oxytocin Group 4, Intranasal Oxytocin Group 5 |
Primary outcome
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
5 secondary outcomes
Reading of the Mind in the Eyes
Time frame: Day 1
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
Resting-state functional connectivity
Time frame: Day 29
Results and safety
The study was stopped early (reason given: All study proceedings stopped prematurely due to Covid-19 restrictions for intranasal formulations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria de las Mercedes Perez Rodriguez, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai; James J. Peters VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Syntocinon 24 Intranasal Units (IU) and Syntocinon 40 Intranasal Units (IU) in people with Borderline Personality Disorder and BPD, run by Maria de las Mercedes Perez Rodriguez at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: All study proceedings stopped prematurely due to Covid-19 restrictions for intranasal formulations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movie for the Assessment of Social Cognition (MASC) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.