大うつ病性障害におけるXEN1101の安全性、忍容性、および有効性を評価するための研究 (X-NOVA)
大うつ病性障害におけるXEN1101の安全性、忍容性、および有効性を評価するための概念実証、無作為化、二重盲検、プラセボ対照、多施設研究
This is a multicenter, Phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of XEN1101 in subjects with Major Depressive Disorder.
調査の概要
詳細な説明
The study is divided into 3 stages: Screening - up to 4 weeks duration; Treatment - 6 weeks duration; Follow-up - 4 weeks duration. The total study duration per subject is estimated to be approximately 14 weeks.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Anaheim、California、アメリカ、92805
- Advanced Research Center
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Lafayette、California、アメリカ、94549
- Sunwise Clinical Research, LLC
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Pico Rivera、California、アメリカ、90660
- California Neuropsychopharmacology Clinical Research Institute
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Riverside、California、アメリカ、92503
- Artemis Institute for Clinical Research
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San Diego、California、アメリカ、92103
- Artemis Institute for Clinical Research
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Florida
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Miami、Florida、アメリカ、33014
- Meridian International Research
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Miami、Florida、アメリカ、33125
- Global Medical Institutes (GMI)
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Miami、Florida、アメリカ、33133
- CCM Clinical Reseach Group, LLC
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Georgia
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Decatur、Georgia、アメリカ、30030
- i-Research, Atlanta
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Marietta、Georgia、アメリカ、30060
- Psych Atlanta, PC
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Savannah、Georgia、アメリカ、31405
- iResearch
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Illinois
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Elgin、Illinois、アメリカ、60123
- Revive Research Institute, Inc.
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Nevada
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Las Vegas、Nevada、アメリカ、89102
- Altea Research
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New Jersey
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Marlton、New Jersey、アメリカ、08009
- Hassman Research Institute
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Toms River、New Jersey、アメリカ、08755
- Bio Behavioral Health
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New York
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Cedarhurst、New York、アメリカ、11516
- Neurobehavioral Research, Inc. (NBR)
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New York、New York、アメリカ、10036
- Manhattan Behavioral Medicine, PLLC
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North Carolina
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Raleigh、North Carolina、アメリカ、27609
- Richard M Weisler and Association
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Texas
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Dallas、Texas、アメリカ、75231
- FutureSearch Trials of Dallas, LP
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Plano、Texas、アメリカ、75093
- AIM Trials
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参加基準
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
Key Inclusion Criteria:
- Be properly informed of the nature and risks of the study and given written informed consent.
- Male or female, aged 18 through 65 years (inclusive) with a body mass index (BMI) ≤35 kg/m².
- Subject must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current MDD and currently in a moderate to severe major depressive episode (MDE), confirmed using the Mini International Neuropsychiatric Interview (MINI).
- Current MDE duration ≥2 months and <24 months at the time of screening.
- Current illness severity that is at least moderate, defined as a score of ≥20 on the HAM-D17 at screening and on Day 1.
- Score ≥20 on the SHAPS at screening and on Day1.
- Must be willing to comply with the study protocol for the full term of the study.
Key Exclusion Criteria:
- A primary psychiatric diagnosis other than MDD as defined by DSM-5 (comorbid anxiety disorders [including agoraphobia, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), and panic disorder] are allowed).
- Concomitant use of antidepressants and/or other disallowed pharmacotherapy (including benzodiazepines).
- History of schizophrenia or other psychotic disorder, MDD with psychotic features, bipolar I or II disorder, or MDD with mixed features.
- History of non-response to >1 antidepressant drug due to lack of efficacy in the current MDE.
- Failing >3 antidepressant drug trials, for any reason, in the current MDE.
- History of non-response to electroconvulsive therapy (ECT) in the past 10 years.
- Active suicidal plan/intent in the past 6 months, or more than 1 lifetime suicide attempt.
- Females who are pregnant, breastfeeding, or planning to become pregnant during the first administration of study drug until 3 months after the last dose of study drug.
- Meets criteria for a substance use disorder within the past 12 months, with the exception of tobacco use, and/or has a positive urine toxicology screen for drugs of abuse.
- Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：XEN1101 10 mg
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day |
XEN1101 oral capsule |
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実験的：XEN1101 20 mg
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day |
XEN1101 oral capsule |
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プラセボコンパレーター：placebo
During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day |
Placebo capsule |
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 |
|---|---|---|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score.
時間枠：From baseline to end of treatment (Week 6).
|
Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated, 10-item scale used to assess the severity of depressive symptoms. Each item is scored from 0 (normal/absent) to 6 (severe), yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity. MADRS total score change from baseline at week 6. |
From baseline to end of treatment (Week 6).
|
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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Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score.
時間枠：From baseline to end of treatment (Week 6).
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Snaith-Hamilton Pleasure Scale (SHAPS) is a validated 14-item self-report questionnaire commonly used to assess anhedonia (reduced ability to experience pleasure). Each of the 14 items is rated from 1 (strongly agree) to 4 (strongly disagree). Total scores range from 14 to 56, with higher scores indicating greater levels of anhedonia. SHAPS total score change from baseline at week 6 |
From baseline to end of treatment (Week 6).
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Change in Beck Anxiety Inventory (BAI) Score.
時間枠：From baseline to end of treatment (Week 6).
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Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire used to assess the severity of anxiety symptoms. Each item is scored on a scale from 0 (not at all) to 3 (severely), yielding a total score ranging from 0 to 63, with higher scores indicating greater anxiety severity. BAI total score change from baseline at week 6 |
From baseline to end of treatment (Week 6).
|
協力者と研究者
捜査官
- スタディディレクター：Study Director、Xenon Pharmaceuticals Inc.
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)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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。