A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment and an Open-label Long-term Extension Treatment With JNJ-99245354 (ITI-1284)
The purpose of this study is to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to placebo when given as an additional (adjunctive) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Study Contact
- 電話番号：844-434-4210
- メール：Participate-In-This-Study1@its.jnj.com
研究場所
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California
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Temecula、California、アメリカ、92591
- 募集
- Inland Psychiatric Medical Group Inc
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Florida
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Miami、Florida、アメリカ、33186
- 募集
- Nuovida Research Center
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Massachusetts
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Springfield、Massachusetts、アメリカ、01103
- 募集
- Voltaire Clinical Research
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New York
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New York、New York、アメリカ、10017
- 募集
- Fieve Clinical Research Inc
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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
Inclusion criteria:
- Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at baseline
- Medically stable on the basis of clinical laboratory tests performed at screening
- History of inadequate response to at least 1 generalized anxiety disorder (GAD)-approved treatment taken at an adequate dose and duration as specified in the protocol for the treatment of ongoing GAD symptoms
- Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the double blind (DB) treatment period of the trial
- Body mass index (BMI) within the range 19-40 kilogram per meter squared (kg/m^2) (inclusive)
Exclusion criteria:
- Within the participant's lifetime, has one of the following confirmed diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) text revision (TR) psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder
- Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders (except simple phobias and social anxiety disorder); b. moderate or severe alcohol or substance use disorders (excluding nicotine); d. moderate or severe major depressive disorder; e. any other psychiatric condition (except for mild major depressive disorder [MDD]) that has been the main focus of treatment
- Montgomery-asberg depression rating scale (MADRS) total score greater than (>)18 at screening or baseline
- Lifetime history of inadequate response to >3 of the approved treatments for GAD at an adequate dose and for an adequate duration
- The participant is taking more than 1 anti depressive therapy (ADT) or is taking ADT + buspirone at screening, regardless of indication, and is unable or unwilling to discontinue additional ADT (or buspirone) prior to baseline
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：4倍
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：JNJ-99245354: Dose 1
Participants will receive JNJ-99245354 dose 1 as an adjunctive therapy once daily for up to 6 weeks in the double blind (DB) period. Eligible participants can enter the open-label (OL) period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks. |
JNJ-99245354 will be administered sublingually.
他の名前：
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実験的：JNJ-99245354: Dose 2
Participants will receive JNJ-99245354 dose 2 as an adjunctive therapy once daily for up to 6 weeks in the DB period. Eligible participants can enter the OL period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks. |
JNJ-99245354 will be administered sublingually.
他の名前：
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プラセボコンパレーター：Placebo
Participants will receive placebo as an adjunctive therapy once daily for up to 6 weeks in the DB period. Eligible participants can enter the OL period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks. |
JNJ-99245354 will be administered sublingually.
他の名前：
Placebo will be administered sublingually. |
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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Change from Baseline to End of Week 6 in Hamilton Anxiety Rating (HAM-A) Scale Total Score
時間枠：Baseline, Week 6
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The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is rated on a 5-point scale ranging from 0=not present to 4=very severe, disabling symptoms. The HAM-A total score ranges from 0 to 56 where higher score indicates greater severity in anxiety. |
Baseline, Week 6
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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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Change from Baseline to the End of Week 6 in Clinical Global Impression-Severity (CGI-S) Anxiety Score
時間枠：Baseline, Week 6
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The CGI-S scale is a standardized assessment tool that the clinician can use to rate the overall severity of illness. The CGI-S asks the clinician: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? CGI-S is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. Here, higher score indicates higher symptom severity. |
Baseline, Week 6
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Change from Baseline to the End of Week 1 in HAM-A Total Score
時間枠：Baseline, Week 1
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The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is rated on a 5-point scale ranging from 0=not present to 4=very severe, disabling symptoms. The HAM-A total score ranges from 0 to 56 where higher score indicates greater severity in anxiety. |
Baseline, Week 1
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協力者と研究者
捜査官
- スタディディレクター：Intra-Cellular Therapies, Inc. Clinical Trial、Intra-Cellular Therapies, Inc.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
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?
IPD プランの説明
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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
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