Oxytocin, Trauma Disclosure and Intrusions
2018年2月1日 更新者：Rene Hurlemann、University Hospital, Bonn
Effects of a Prolonged Oxytocin Treatment on Intrusions and Amygdala Reactivity in an Analogue Trauma Model
Severe traumatic experiences such as falling victim to assault, torture, or rape have deleterious effects.
Clinical manifestations include intrusions, avoidance behavior, and hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala and hypofunction of prefrontal cortex (PFC) subregions.
In up to 50 % of the cases, resilience is not sufficient and trauma-exposed individuals develop posttraumatic stress disorder (PTSD).
Oxytocin (OXT) is a hypothalamic peptide hormone that exerts anxiolytic effects.
Recent clinical trials provide preliminary evidence that post-trauma administration of OXT could be effective as a preventive intervention for PTSD in a subsample of individuals exhibiting early PTSD symptoms prior to the onset of the disorder.
However, the underlying neurobiological mechanisms are unclear.
Therefore, the rationale of the present project is to expose a sample of healthy participants to experimental trauma in order to explore the circuit mechanisms by which OXT influences, and interferes with, traumatic experience.
Functional magnetic resonance imaging (fMRI) will be employed in order to elucidate the long-term effects of intranasal OXT on trauma-induced intrusions, amygdala and PFC responses during an emotional face matching task and resting state functional connectivity.
調査の概要
詳細な説明
Participants will be exposed to an experimental trauma (i.e. a highly aversive movie) at days 1 and 4 of the study.
After the first experimental trauma and after the first functional magnetic resonance imaging (fMRI) measurement, the participants will receive intranasal OXT or placebo in three different groups (1.
OXT for six days, 2. OXT for three days and then placebo for three days, 3. placebo for six days).
The same fMRI tasks will be used after the first and second trauma exposure (i.e. one measurement before the treatment and one measurement after three days of treatment).
研究の種類
介入
入学 (実際)
70
段階
- 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
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Bonn、ドイツ、53105
- Department of Psychiatry, University of Bonn
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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～40年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
Inclusion Criteria:
- Healthy female volunteers
- Right-handed
Exclusion Criteria:
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Hormonal contraception
- MRI contraindication (e.g. metal in body, claustrophobia)
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：並列代入
- 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 |
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アクティブコンパレータ：Oxytocin (6 days)
Intranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure and three days after the second trauma movie exposure (24 IU per day)
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Intranasal administration, 24 international units (IU) oxytocin.
他の名前：
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アクティブコンパレータ：Oxytocin (3 days)
Intranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure (24 IU per day) and placebo nasal spray for three days after the second trauma movie exposure
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Intranasal administration, 24 international units (IU) oxytocin.
他の名前：
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プラセボコンパレーター：Placebo
Placebo nasal spray for six days
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プラセボ点鼻スプレーには、ペプチド自体を除いて同一の成分が含まれています。
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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 |
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Total number of intrusions following the first trauma movie exposure.
時間枠：Three days following the first trauma movie exposure.
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The participants will be asked to complete intrusion diaries at home in the evening of the days 1 to 3. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness.
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Three days following the first trauma movie exposure.
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Total number of intrusions following the second trauma movie exposure.
時間枠：Three days following the second trauma movie exposure.
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The participants will be asked to complete intrusion diaries at home in the evening of the days 4 to 6. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness.
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Three days following the second trauma movie exposure.
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Neural responses to emotional faces in the amygdala.
時間枠：Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
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Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli.
The investigators specifically plan to investigate amygdala responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions.
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Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
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Neural responses to emotional faces in the prefrontal cortex.
時間枠：Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
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Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli.
The investigators specifically plan to investigate prefrontal cortex responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions.
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Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
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fMRI resting state data
時間枠：Functional data will be acquired for 6 min.
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Participants will be instructed to lie still with open eyes during the resting state measurement and not think of anything in particular.
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Functional data will be acquired for 6 min.
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Trauma disclosure (time spend discussing the movie)
時間枠：Six days following the first trauma movie exposure.
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The intrusion diaries will contain a question for how long participants discussed the trauma movie.
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Six days following the first trauma movie exposure.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Changes in pupil diameter in response to the trauma movie
時間枠：2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Changes in pupil diameter will be measured.
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2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Changes in skin conductance level in response to the trauma movie
時間枠：2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Changes in skin conductance level will be measured.
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2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Changes in respiration rate in response to the trauma movie
時間枠：2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Changes in respiration rate will be measured.
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2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Salivary oxytocin concentrations
時間枠：Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
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Saliva samples will be collected before and after the trauma movie to assess changes in oxytocin concentrations.
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Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
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Salivary cortisol concentrations
時間枠：Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
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Saliva samples will be collected before and after the trauma movie to assess changes in cortisol concentrations.
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Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
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Questionnaire measurement of mood (PANAS)
時間枠：10 min before and 10 min after the trauma movie.
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Positive and negative affect will be assessed via self-rating questionnaire 'The Positive and Negative Affect Schedule' using a categorical 5 point scale.
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10 min before and 10 min after the trauma movie.
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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。
捜査官
- 主任研究者：René Hurlemann, MD, PhD、University of Bonn
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。
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 (実際)
2016年6月1日
一次修了 (実際)
2017年3月18日
研究の完了 (実際)
2017年3月18日
試験登録日
最初に提出
2018年1月28日
QC基準を満たした最初の提出物
2018年2月1日
最初の投稿 (実際)
2018年2月8日
学習記録の更新
投稿された最後の更新 (実際)
2018年2月8日
QC基準を満たした最後の更新が送信されました
2018年2月1日
最終確認日
2018年2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。
プラセボの臨床試験
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Shanghai Hengrui Pharmaceutical Co., Ltd.完了
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Palacky University完了