Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception
2018년 1월 12일 업데이트: Yale University
Oxytocin Pilot: Oxytocin and Face Perception
The objective of this study is to investigate the effects of oxytocin on social behavior and brain activity using EEG and the event-related potential (ERP) technique.
The value of EEG is its high temporal specificity, enabling precision in the timing of social behavior to be addressed.
In order to elicit social responses in the human brain, a variety of social and emotional visual stimuli will be presented during EEG recording, namely infant and adult faces and houses.
Brain responses after intranasal oxytocin will then be compared with placebo, to examine the effect of intranasal oxytocin on central nervous system activity.
We hypothesize that intranasal oxytocin will enhance the neural response to social stimuli (infant and adult faces) but not to non-social stimuli (houses).
연구 개요
연구 유형
중재적
등록 (실제)
26
단계
- 초기 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale Child Study Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- Adults ages 18-64
- Good medical health
- Ability to understand and speak English
Exclusion Criteria:
- Pregnancy
- Medical Illnesses: Moderate or severe acute or chronic medical illnesses (e.g. cardiac disease, diabetes, epilepsy, influenza).
- Cardiovascular risk factors: History of hypertension with baseline blood pressure above 140 mm Hg (systolic) over 90 mm Hg (diastolic). Also any history of syncope and/or baseline blood pressure below 100 mm Hg (systolic).
- CNS disease: Known history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), other central nervous system disease, or history of head trauma which resulted in a persistent neurologic deficit or loss of consciousness > 3 minutes.
- Medication status: Individuals on stable doses of a neuroleptic and/or an antidepressant medication for at least the past 6 weeks will be allowed to participate in this study. The use of other psychotropic medications will not be allowed. Females taking contraceptive hormones will not be able to participate in the study.
- A history of seizures or current use of anticonvulsants; history of head injury with loss of consciousness
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Oxytocin
Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
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24 International Units of Oxytocin in a Nasal Spray
다른 이름들:
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위약 비교기: Placebo
Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
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Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Amplitude Social
기간: Duration of 30 minutes
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The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces).
This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response.
The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs.
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Duration of 30 minutes
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Amplitude Non-Social
기간: Duration of 30 minutes
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The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses).
This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response.
The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs.
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Duration of 30 minutes
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Latency Social
기간: Duration of 30 minutes
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The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces).
This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response.
The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition.
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Duration of 30 minutes
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Latency Non-Social
기간: Duration of 30 minutes
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The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses).
This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response.
The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition.
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Duration of 30 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Depression
기간: Within 20 minutes of study visit commencing
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The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961).
Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits.
It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues.
This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire.
Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression).
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Within 20 minutes of study visit commencing
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Smoking
기간: Within 30 minutes of study visit commencing
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Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991) to assess smoking behavior.
These measures are included to characterize the sample in respect of substance use.
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Within 30 minutes of study visit commencing
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Anxiety
기간: Within 20 minutes of study visit commencing
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The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970).
Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits.
It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues.
Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety.
A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious.
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Within 20 minutes of study visit commencing
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Stress
기간: Within 20 minutes of study visit commencing
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The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983).
It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample.
The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress.
A score of 21+ is considered to indicate that participants have higher than average stress.
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Within 20 minutes of study visit commencing
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Early Experience
기간: Within 20 minutes of study visit commencing
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The investigators will employ the Parental Bonding Instrument (Parker, Tupling, & Brown, 1979) to assess the early relationship experiences participants have with their caregivers.
Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis.
There are 12 items that capture parental care and 13 items that capture parental overprotection.
Items are scored on a 4-point likert scale from "very like" to "very unlike".
The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection).
For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39.
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Within 20 minutes of study visit commencing
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Number of Participants Endorsing Substance Use
기간: Within 30 minutes of study visit commencing
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The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, & O'Brien, 1980) to assess for current substance use.
This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance.
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Within 30 minutes of study visit commencing
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Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer
기간: Within 30 minutes of study visit commencing
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Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.
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Within 30 minutes of study visit commencing
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Linda C Mayes, MD, Yale University
- 연구 책임자: Helena JV Rutherford, PhD, Yale University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 9월 1일
기본 완료 (실제)
2015년 12월 1일
연구 완료 (실제)
2015년 12월 1일
연구 등록 날짜
최초 제출
2014년 9월 4일
QC 기준을 충족하는 최초 제출
2014년 9월 9일
처음 게시됨 (추정)
2014년 9월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 1월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 1월 12일
마지막으로 확인됨
2018년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .