범불안장애 환자의 단독요법 치료제로서 ITI-1284에 대한 연구
범불안장애 치료에 부적절한 반응을 보이는 범불안장애 환자의 보조 치료제로서 ITI-1284의 효능, 안전성 및 내약성을 평가하기 위한 다기관, 무작위, 이중 맹검, 위약 대조 연구
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- 모병
- University of Alabama at Birmingham
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Arkansas
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Little Rock, Arkansas, 미국, 72211
- 모병
- Woodland International Research Group
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Rogers, Arkansas, 미국, 72758
- 모병
- Woodland Research Northwest
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California
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Culver City, California, 미국, 90230
- 모병
- Proscience Research Group
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Encino, California, 미국, 91316
- 모병
- Wake Research PRI Encino
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Encino, California, 미국, 91316
- 모병
- Leading Edge Research
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Los Angeles, California, 미국, 90025
- 모병
- CalNeuro Research
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Oceanside, California, 미국, 92056
- 모병
- Excell Research Inc
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Sherman Oaks, California, 미국, 91403
- 모병
- California Neuroscience Research
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Upland, California, 미국, 91786
- 완전한
- Pacific Clinical Research Medical Group
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Walnut Creek, California, 미국, 94596
- 모병
- Sunwise Clinical Research
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Connecticut
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Farmington, Connecticut, 미국, 06032
- 모병
- University of Connecticut Health Center
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Florida
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Gainesville, Florida, 미국, 32607
- 완전한
- Sarkis Clinical Trials
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Miami, Florida, 미국, 33176
- 모병
- Miami Dade Medical Research Institute
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Tampa, Florida, 미국, 33613
- 모병
- University of South Florida
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Georgia
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Decatur, Georgia, 미국, 30030
- 모병
- iResearch Atlanta LLC
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Mississippi
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Flowood, Mississippi, 미국, 39232
- 모병
- Precise Clinical Research, Inc.
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New York
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Brooklyn, New York, 미국, 11235
- 모병
- SPRI Clinical Trials, LLC
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Buffalo, New York, 미국, 14215
- 모병
- University of Buffalo
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Staten Island, New York, 미국, 10314
- 모병
- Richmond Behavioral Associates
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Ohio
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Columbus, Ohio, 미국, 43210
- 모병
- The Ohio State University
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Oklahoma
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Norman, Oklahoma, 미국, 73071
- 모병
- Sooner Clinical Research
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Pennsylvania
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Media, Pennsylvania, 미국, 19063
- 모병
- Suburban Research Associates
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Texas
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Dallas, Texas, 미국, 75243
- 모병
- Relaro Medical Trials
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Washington
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Bellevue, Washington, 미국, 98007
- 모병
- Northwest Clinical Research Center
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Blagoevgrad, 불가리아, 2700
- 모병
- Medical Center Sv Dimitar Blagoevgrad
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Kardzhali, 불가리아, 6600
- 모병
- Medical Center Lifemed
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Pleven, 불가리아, 5800
- 모병
- Medical Center Medconsult-Pleven
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Plovdiv, 불가리아, 4004
- 모병
- Medical Center Mentalcare OOD
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Rousse, 불가리아, 7003
- 모병
- Mental Health Center - Rousse
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Sofia, 불가리아, 1680
- 모병
- Medical Center Intermedica, OOD
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Sofia, 불가리아, 1408
- 모병
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
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Sofia, 불가리아, 1510
- 모병
- Medical Center Hera EOOD
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Targovishte, 불가리아, 7700
- 모병
- Medical center - VAS OOD
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Belgrade, 세르비아, 11000
- 모병
- University Clinical Center of Serbia
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Belgrade, 세르비아, 11000
- 모병
- Institute of Mental Health Serbia
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Belgrade, 세르비아, 11000
- 모병
- Clinical Center Dr Dragisa Misovic Dedinje
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Belgrade, 세르비아, 11000
- 모병
- University Clinical Center of Serbia 1
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Kovin, 세르비아, 26220
- 모병
- Special Neuropsychiatric Hospital Kovin
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Kragujevac, 세르비아, 34000
- 모병
- University Clinical Center Kragujevac
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Niš, 세르비아, 18000
- 모병
- University Clinical Center NIS
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Novi Kneževac, 세르비아, 23330
- 모병
- Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
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Bratislava, 슬로바키아, 821 01
- 모병
- Psychiatricka Ambulancia Mentum S.R.O.
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Rimavská Sobota, 슬로바키아, 979 01
- 모병
- Psychiatricka Ambulancia Psycholine S.R.O.
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Svidník, 슬로바키아, 08901
- 모병
- Centrum Zdravia R.B.K. S.R.O. Poliklinika Medic Sk
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Vranov nad Topľou, 슬로바키아, 093 01
- 모병
- Crystal Comfort s.r.o.
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Bialystok, 폴란드, 15272
- 모병
- Prywatne Gabinety Lekarskie PROMEDICUS
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Bydgoszcz, 폴란드, 85-080
- 모병
- Przychodnia Srodmiescie SP. z o.o.
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Gdansk, 폴란드, 80 283
- 모병
- Centrum Zdrowia Alcea
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Leszno, 폴란드, 64-100
- 모병
- Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
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Torun, 폴란드, 87 100
- 모병
- Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Provide written informed consent before the initiation of any study specific procedures;
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At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:
- HAM-A Total score of ≥ 22;
- HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
- CGI-S score of ≥ 4;
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History of inadequate response (< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire [ATRQ] for GAD) to at least 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 milligram [mg], venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms.
Exclusion Criteria:
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Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- Bipolar Disorder;
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MADRS total score > 18 at Screening or Baseline;
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In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
- At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
- At Screening or Baseline MADRS Item 10 score ≥ 5; or
- The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator;
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Lifetime history of failure to respond to > 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: ITI-1284 10mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration. |
ITI-1284 10 mg tablet, taken once daily, sublingual administration. |
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실험적: ITI-1284 20mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration. |
ITI-1284 20 mg tablet, taken once daily, sublingual administration. |
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위약 비교기: Placebo
Matching placebo tablet, taken once daily, sublingual administration |
Matching placebo tablet, taken once daily, sublingual administration |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hamilton Anxiety Rating Scale (HAM-A)
기간: 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). It is comprised of 14 items that are 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 with a higher score indicating increased severity of anxiety symptoms. |
Week 6
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical Global Impression Scale-Severity (CGI-S)
기간: Week 6
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The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients) |
Week 6
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공동 작업자 및 조사자
수사관
- 연구 책임자: Intra-Cellular Therapies,Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .