Neurobiological Bases of Paternal Nurturance
2017年4月27日 更新者：James K. Rilling, PhD
Biological Bases of Individual Variation in Paternal Nurturance
The overall goal of this project is to identify the genetic, hormonal, and neurobiological influences on paternal nurturing behavior and to determine if fathers' neural responses to infants can be modulated by neuropeptides known to play a role in parenting in experimental animal models.
The aim is to determine if pharmacological manipulation of central oxytocin (OT) and vasopressin (AVP) levels influences the neural response to viewing pictures of one's own infant or to hearing cry stimuli. In a double-blind procedure, fathers with 1-3 year old children will be scanned on two separate occasions; once under the influence of OT/AVP and once under the influence of placebo. Fathers will be randomized to either OT or AVP, and order of administration of drug and placebo will counterbalanced across subjects. Fathers will be scanned while viewing pictures of their own and an unknown child and while listening to unknown infant cry stimuli.
The investigators hypothesize:
- OT will augment the ventral tegmental area (VTA), ventral striatum and medial orbitofrontal cortex (mOFC) response to viewing pictures of one's own child, and will augment the primary auditory cortex (AI) response of fathers to infant cries.
- AVP will augment the lateral septum response to viewing own child pictures.
調査の概要
詳細な説明
30 fathers of children aged 1-3 will participate in two functional imaging sequence (fMRI) sessions, once under the influence of OT/AVP, and once under the influence of placebo.
Fathers will be restricted to men who are living with their biological child and an adult partner (male or female) that they are in a committed relationship with.
All fathers will receive two fMRI scans on two different occasions, separated by 2-10 days.
15 fathers will be randomized to intranasal OT, the other 15 will be randomized to intranasal AVP.
Within each drug group, the order of administration of drug and placebo will counterbalanced across subjects, such that 15 will receive OT/AVP first, and 15 will receive OT/AVP second.
During the fMRI scans, fathers will view pictures of their own and unknown children, as well as unknown adults.
Afterwards, while still in the scanner, they will listen to infant cry and control stimuli.
After exiting the scanner, fathers will again listen to the cry stimuli and will rate their emotional reaction to the cry stimuli on the following dimensions using a 7 point likert scale: irritated, sympathetic, alarmed, angry, upset, compassionate, distressed, annoyed, and tender.
研究の種類
介入
入学 (実際)
35
段階
- 適用できない
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
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Georgia
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Atlanta、Georgia、アメリカ、30307
- Emory University Hospital
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Atlanta、Georgia、アメリカ、30322
- Emory University 1462 Clifton Rd
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-
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年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- above 18
- biological fathers of 1-3 year old infants who are currently cohabitating with the child's mother
- normal or corrected-to-normal vision of 20/40
Exclusion Criteria:
- current or past history of mental illness
- active medical or neurological disorder
- current or past history of alcohol or drug dependence
- claustrophobic (at the discretion of the PI with subject consultation)
- history of seizures or other neurological disorder
- history of hypertension, cardiovascular disease, nephritis, diabetes or other endocrine diseases or malignancy
- ferrous metal in any part of the body
- history of asthma or migraine headaches (can be included at the discretion of the study physician or nurse practitioner if episodes are infrequent and no active problems at time of study, not medicated)
- history of head trauma or psychiatric illness, as well as those who are receiving or have received over the past year, medication with known psychoactive effects (included at the discretion of the PI as these are exclusion criteria due to data quality concerns and not safety concerns; head trauma should be minimal enough deemed by the PI)
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：OT + placebo
The OT + placebo group will self-administer no more than 1 ml solution of oxytocin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.
The order of administration of drug and placebo will counterbalanced across subjects, such that half will receive OT first, and half will receive OT second.
|
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
他の名前：
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
|
|
実験的：AVP + placebo
The AVP + placebo group will self-administer no more than 1 ml solution of vasopressin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.
The order of administration of drug and placebo will counterbalanced across subjects, such that half will receive AVP first, and half will receive AVP second.
|
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
他の名前：
|
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 |
|---|---|---|
|
Mean Percent Signal Change in Ventral Tegmental Area (VTA)
時間枠：Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Changes will be assessed in the OT group only per protocol.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in Right Ventral Striatum
時間枠：Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Changes will be assessed in the OT group only per protocol.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in Right Medial Orbitofrontal Cortex
時間枠：Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Changes will be assessed in the OT group only per protocol.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in Caudate Nucleus
時間枠：Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in the Visual Cortex
時間枠：Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in the Anterior Cingulate Cortex
時間枠：Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
|
Baseline, Visit 2 (Up to 10 days)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Plasma Levels of Vasopressin (AVP)
時間枠：Baseline, Visit 2 (Up to 10 days)
|
Peripheral levels of AVP will be assessed via assay of plasma collected.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Change in Plasma Levels of Oxytocin (OT)
時間枠：Baseline, Visit 2 (Up to 10 days)
|
Peripheral levels of OT will be assessed via assay of plasma collected.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Difference in Cry Rating Scores Between OT and Placebo
時間枠：Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under OT and placebo treatment on a 7-point likert scale.
Sixteen adjectives will be used to describe two different cries.
Participants will rate each cry from 1-7 where one represents "not at all" and 7 represents "extremely".
Difference is defined as OT minus placebo scores.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Difference in Cry Rating Scores Between AVP and Placebo
時間枠：Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under AVP and placebo treatment on a 7-point likert scale.
Sixteen adjectives will be used to describe two different cries.
Participants will rate each cry from 1-7 where one represents "not at all" and 7 represents "extremely".
Difference is defined as AVP minus placebo scores.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in Primary Auditory Cortex
時間枠：Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Changes will be assessed in the OT group only per protocol.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in Right Lateral Septum
時間枠：Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between AVP treatment and placebo treatments (AVP-PL) from functional magnetic resonance imaging (fMRI).
Changes will be assessed in the AVP group only per protocol.
|
Baseline, Visit 2 (Up to 10 days)
|
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：James K Rilling, Ph.D.、Emory University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
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8月1日
一次修了 (実際)
2016年2月1日
研究の完了 (実際)
2016年2月1日
試験登録日
最初に提出
2014年8月20日
QC基準を満たした最初の提出物
2014年8月20日
最初の投稿 (見積もり)
2014年8月22日
学習記録の更新
投稿された最後の更新 (実際)
2017年6月5日
QC基準を満たした最後の更新が送信されました
2017年4月27日
最終確認日
2017年4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。