慢性 PTSD に対するサイロシビン支援認知処理療法
慢性心的外傷後ストレス障害に対するサイロシビン支援による集中認知処理療法: 非盲検試験
This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Current front-line treatments for Posttraumatic stress disorder (PTSD) are ineffective for up to half of patients, with serious medical and societal consequences. It is imperative to improve the efficacy of front-line treatment options, such as cognitive processing therapy (CPT). CPT is an effective treatment for PTSD, including when delivered intensively (i.e., multiple sessions over 7 days). However, a substantial proportion of patients continue to meet criteria for PTSD or have residual PTSD symptoms post-treatment. Psilocybin-assisted CPT may be a potential solution, as preliminary evidence supports the potential of psilocybin to alleviate symptoms of PTSD.
Fifteen participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT, and 2 psychotherapy sessions related to psilocybin over 7 days. Participants will complete clinician-administered scales, self-reported mental health questionnaires, and use a wearable device. After the 1-week interventional period, participants will enter a 12-weeks follow-up period.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Ontario
-
Toronto、Ontario、カナダ、M5S 1A1
- St. Michael's Hospital, Unity Health Toronto
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer assessed by study psychiatrist;
- Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms;
- Are willing to refrain from taking any psychiatric medications during the study period.
Exclusion Criteria:
- Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;
- Have a history of or a current primary diagnosis of psychotic disorder, schizophrenia, delusional disorder, borderline personality disorder, schizoaffective disorder, bipolar disorder or, dissociative identity disorder;
- Have evidence or history of coronary artery disease or cerebral or peripheral vascular disease, hepatic disease with abnormal liver enzymes, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration;
- Have hypertension using the standard criteria of the American Heart Association (values of 140/90 or higher assessed on three separate occasions;
- History of seizure disorder;
- Uncontrolled insulin-dependent diabetes;
- Recent stroke, intracranial or subarachnoid hemorrhage (< 1 year from signing of informed consent form [ICF]), recent myocardial infarction (< 1 year from signing of ICF), clinically significant arrhythmia (< 1 year from signing of ICF);
- Have liver disease with the exception of asymptomatic subjects with Hepatitis C who have previously undergone evaluation and successful treatment;
- Lifetime history of substance-induced psychosis;
- Lifetime history of substance use disorder with a hallucinogen;
- History of alcohol use disorder in the past 3 months.
研究計画
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Experimental
Single dose of psilocybin 25mg + Massed cognitive processing therapy |
Participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT, and 2 psychotherapy sessions related to psilocybin over 7 days. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility and tolerability
時間枠：Up to 16 weeks
|
Recruitment rate, withdrawal rate, adherence rate, data completion rate, percentage of participants with severe adverse events. |
Up to 16 weeks
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Childhood Trauma Questionnaire-short form (CTQ-SF)
時間枠：スクリーニング
|
スクリーニング
|
|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score
時間枠：Up to 16 weeks
|
The CAPS-5 is a semi-structured clinical interview used to assess index history of DSM-5-defined traumatic event exposure, including the most distressing event, time since exposure, and total number of exposures, as well as frequency and severity of posttraumatic stress symptoms. |
Up to 16 weeks
|
|
Posttraumatic stress disorder Checklist-5 (PCL-5)
時間枠：Up to 16 weeks
|
The PCL-5 is self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the DSM-5 symptoms of PTSD. |
Up to 16 weeks
|
|
Patient Health Questionnaire-9 (PHQ-9)
時間枠：Up to 16 weeks
|
The PHQ-9 is a self-rated measure of depressive symptom severity in the past two weeks. Each of the nine items is rated on a Likert scale, ranging from 0 (not at all) to 3 (nearly every day), and summed for a total score between 0 (no symptoms) to 27 (most severe). |
Up to 16 weeks
|
|
Generalized Anxiety Disorder Scale, 7-item (GAD-7)
時間枠：Up to 16 weeks
|
Total score ranges from 0 to 21; a higher score denotes greater symptom severity. |
Up to 16 weeks
|
|
Dissociative Experiences Scale II (DES-II)
時間枠：Up to 13 weeks
|
The Dissociative Experiences Scale II is a 28-item, self-report measure of dissociative experiences. |
Up to 13 weeks
|
|
Pittsburgh Sleep Quality Index (PSQI)
時間枠：Up to 13 weeks
|
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. |
Up to 13 weeks
|
|
World Health Organization Well-Being Index, 5-item (WHO-5)
時間枠：Up to 16 weeks
|
The WHO-5 is a measure of overall well-being, rated on a scale of 0 to 25, with higher scores denoting higher quality of life. |
Up to 16 weeks
|
|
Quality of relationships inventory (QRI)
時間枠：Up to 13 weeks
|
The QRI is a self-report questionnaire used to determine the quality relationships consisting of 25 items that are evaluated on a 4-point Likert scale ranging from 1 = not true to 4 = almost always true. |
Up to 13 weeks
|
|
Inventory of psychosocial functioning (IPF)
時間枠：Up to 13 weeks
|
The IPF is an 80-item self-report instrument measuring PTSD-related functional impairment in the past 30 days. |
Up to 13 weeks
|
|
Posttraumatic Maladaptive Beliefs Scale (PMBS)
時間枠：Up to 13 weeks
|
The PMBS is a 15-item scale that was developed to measure maladaptive beliefs about life circumstances that may occur following trauma exposure. |
Up to 13 weeks
|
|
Brief Experiential Avoidance Questionnaire (BEAQ)
時間枠：Up to 13 weeks
|
The BEAQ is a 15-item self-report measure of experiential avoidance. |
Up to 13 weeks
|
|
24-items Multidimensional Psychological Flexibility Inventory (MPFI-24)
時間枠：Up to 13 weeks
|
The MPFI-24 is a 24-item self-report scale developed to assess the specific components of psychological flexibility and inflexibility. |
Up to 13 weeks
|
|
Working Alliance Inventory- Short Form (WAI-SF)
時間枠：Up to Day 7
|
The WAI-SF is a patient-rated measure of the alliance between a therapist and client. |
Up to Day 7
|
|
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
時間枠：Up to 13 weeks
|
The DERS-SF is an 18-item measure used to identify emotional regulation issues in adults. |
Up to 13 weeks
|
|
Self-Compassion Scale-Short Form (SCS-SF)
時間枠：Up to 13 weeks
|
The SCS-SF is a 12-item self-report measure of self-compassion. |
Up to 13 weeks
|
|
Psychological Insight Questionnaire (PIQ)
時間枠：Up to Day 3
|
The PIQ is a 23-item self-report measure of acute experiences of insight (e.g. awareness into emotions, behaviors, beliefs, memories, or relationships) after taking a psychedelic. |
Up to Day 3
|
|
Emotional Breakthrough Inventory (EBI)
時間枠：Up to Day 3
|
The EBI is a measure of emotional release/breakthrough experienced during the acute psychedelic state. |
Up to Day 3
|
|
Altered States of Consciousness Rating Scale (ASC)
時間枠：Up to Day 3
|
The ASC measures altered states of consciousness. |
Up to Day 3
|
|
Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ)
時間枠：Up to Day 3
|
The APEQ is a psychometric self-report tool for measuring aspects of the acute psychedelic experience that are associated with longer-term changes in psychological flexibility. |
Up to Day 3
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Effect on digital physiological passive data collected through the use of a wearable device
時間枠：Up to 16 weeks
|
Example: sleep, activity |
Up to 16 weeks
|
協力者と研究者
協力者
協力者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 23-230
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。