Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception
2018年1月12日 更新者：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).
調査の概要
研究の種類
介入
入学 (実際)
26
段階
- 初期フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Connecticut
-
New Haven、Connecticut、アメリカ、06520
- Yale Child Study Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～64年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
24 International Units of Oxytocin in a Nasal Spray
他の名前：
|
|
プラセボコンパレーター：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.
|
Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Amplitude Social
時間枠：Duration of 30 minutes
|
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.
|
Duration of 30 minutes
|
|
Amplitude Non-Social
時間枠：Duration of 30 minutes
|
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.
|
Duration of 30 minutes
|
|
Latency Social
時間枠：Duration of 30 minutes
|
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.
|
Duration of 30 minutes
|
|
Latency Non-Social
時間枠：Duration of 30 minutes
|
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.
|
Duration of 30 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Depression
時間枠：Within 20 minutes of study visit commencing
|
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).
|
Within 20 minutes of study visit commencing
|
|
Smoking
時間枠：Within 30 minutes of study visit commencing
|
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.
|
Within 30 minutes of study visit commencing
|
|
Anxiety
時間枠：Within 20 minutes of study visit commencing
|
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.
|
Within 20 minutes of study visit commencing
|
|
Stress
時間枠：Within 20 minutes of study visit commencing
|
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.
|
Within 20 minutes of study visit commencing
|
|
Early Experience
時間枠：Within 20 minutes of study visit commencing
|
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.
|
Within 20 minutes of study visit commencing
|
|
Number of Participants Endorsing Substance Use
時間枠：Within 30 minutes of study visit commencing
|
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.
|
Within 30 minutes of study visit commencing
|
|
Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer
時間枠：Within 30 minutes of study visit commencing
|
Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.
|
Within 30 minutes of study visit commencing
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Linda C Mayes, MD、Yale University
- スタディディレクター：Helena JV Rutherford, PhD、Yale University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年9月1日
一次修了 (実際)
2015年12月1日
研究の完了 (実際)
2015年12月1日
試験登録日
最初に提出
2014年9月4日
QC基準を満たした最初の提出物
2014年9月9日
最初の投稿 (見積もり)
2014年9月12日
学習記録の更新
投稿された最後の更新 (実際)
2018年1月17日
QC基準を満たした最後の更新が送信されました
2018年1月12日
最終確認日
2018年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。