ACP-211 단일요법으로 항우울제 반응이 부적절한 주요우울장애 치료 (NORLIGHT)
항우울제 치료에 불충분한 반응을 보이는 주요 우울 장애 성인 환자를 대상으로 ACP-211 단독요법의 효능과 안전성에 대한 이중맹검, 위약대조, 병렬군 연구
The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).
The main questions the study aims to answer are:
- Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression?
- What adverse events do participants have when taking ACP-211?
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Sandy Filosi
- 전화번호: +1(609) 250-6920
- 이메일: sfilosi@ACADIA-Pharm.com
연구 연락처 백업
- 이름: Lori Lykens
- 전화번호: +1(609) 250-6917
- 이메일: lori.lykens@acadia-pharm.com
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- 빼는
- University of Alabama at Birmingham
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California
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Chino, California, 미국, 91710
- 모병
- Inland Psychiatric Medical Group
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Glendale, California, 미국, 91107
- 모병
- Behavioral Research Specialists, LLC
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La Jolla, California, 미국, 92037
- 모병
- Kadima Neuropsychiatry Institute
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Orange, California, 미국, 92866
- 모병
- PNS Clinical Research LLC dba ATP Clinical Research
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West Hills, California, 미국, 91307
- 모병
- Focus Clinical Research, LLC d/b/a Alliance Clinical West Hills
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Colorado
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Denver, Colorado, 미국, 80209
- 모병
- Mountain View Clinical Research
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Florida
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Fort Myers, Florida, 미국, 33901
- 모병
- New Access Research and Medical Services, Inc.
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Hollywood, Florida, 미국, 33021
- 모병
- The Medici Medical Research
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Largo, Florida, 미국, 33777
- 빼는
- Sandhill Research, LLC/DBA Accel Research Sites
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Orlando, Florida, 미국, 32801
- 모병
- Clinical Neuroscience Solutions, Inc.
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Tampa, Florida, 미국, 33629
- 모병
- IPTB Clinical Research
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West Palm Beach, Florida, 미국, 33407
- 모병
- Neuroscience Research Institute, Inc.
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Massachusetts
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Watertown, Massachusetts, 미국, 02472
- 모병
- Adams Clinical, Inc.
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Worcester, Massachusetts, 미국, 01608
- 모병
- Vitalix Clinical, Inc.
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Mississippi
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Flowood, Mississippi, 미국, 39232
- 모병
- Precise Research Centers
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Missouri
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Saint Charles, Missouri, 미국, 63304
- 모병
- St. Charles Psychiatric Associates, Inc. dba Midwest Research Group
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Nebraska
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Lincoln, Nebraska, 미국, 68526
- 모병
- Alivation Research, LLC
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Nevada
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Las Vegas, Nevada, 미국, 89134
- 모병
- Redbird Research LLC
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New Jersey
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Marlton, New Jersey, 미국, 08053
- 빼는
- CenExel Hassman Research Institute, LLC
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New York
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Brooklyn, New York, 미국, 11229
- 모병
- Integrative Clinical Trials LLC
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North Carolina
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Cary, North Carolina, 미국, 27511
- 모병
- Magnolia Clinical Research, LLC
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Ohio
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North Canton, Ohio, 미국, 44720
- 모병
- Neuro-Behavioral Clinical Research
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Texas
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Houston, Texas, 미국, 77030
- 모병
- Baylor College of Medicine
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Houston, Texas, 미국, 77081
- 빼는
- Dynamed Clinical Research LP d/b/a DM Clinical Research
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Katy, Texas, 미국, 77450
- 모병
- Olympus Clinical Research, LLC
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The Woodlands, Texas, 미국, 77381
- 모병
- Family Psychiatry of The Woodlands
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Utah
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Salt Lake City, Utah, 미국, 84105
- 모병
- Aura Wellness
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults ≥18 and ≤65 years of age
- Provides written informed consent
- Clinical diagnosis of MDD
- History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode
- Currently treated with an approved antidepressant at a stable dose prior to Screening
- MADRS total score ≥28, CGI-S score ≥4, and QIDS-SR16 score ≥14 at Screening and Baseline
- Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation
Exclusion Criteria:
- Current diagnosis of certain personality disorders or persistent depressive disorder
- Recent substance use disorders, excluding caffeine or nicotine
- Active suicidal risk or recent suicidal attempt
- History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features
- Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD
- History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy)
- Allergy or sensitivity to ketamine or esketamine
- Significant cardiovascular disease
- Positive history of hepatitis B, hepatitis C, or HIV infection
- Unstable diabetes or uncontrolled medical conditions
- Positive urine drug test for an illicit drug or cannabis
- Received neuromodulation therapies (ECT, TMS, VNS, DBS) in the current depressive episode
- Recent initiation or change in psychotherapy
Additional inclusion/exclusion criteria apply. Participants will be evaluated at Screening to ensure that all criteria for study participation are met.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: ACP-211 600 mg
ACP-211 600 mg, administered orally twice weekly |
ACP-211 monotherapy |
|
실험적: ACP-211 300 mg
ACP-211 300 mg, administered orally twice weekly |
ACP-211 monotherapy |
|
위약 비교기: Placebo
Matching placebo, administered orally twice weekly |
Placebo control |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28
기간: Baseline and Day 28
|
The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity. |
Baseline and Day 28
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in MADRS Total Score at Scheduled Postbaseline Visits
기간: Baseline through Day 28
|
Baseline through Day 28
|
|
|
Proportion of Subjects in Remission at Scheduled Postbaseline Visits (MADRS ≤10)
기간: Up to Day 28
|
Up to Day 28
|
|
|
Proportion of Subjects With Response at Scheduled Postbaseline Visits (≥50% Reduction From Baseline in MADRS Total Score)
기간: Up to Day 28
|
Up to Day 28
|
|
|
Change From Baseline in MADRS Total Score at Day 2
기간: Baseline and Day 2 (24 hours postdose)
|
The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity. |
Baseline and Day 2 (24 hours postdose)
|
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Scheduled Postbaseline Visits
기간: Baseline through Day 28
|
The CGI-S is a clinician-rated assessment of illness severity scored on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater illness severity. |
Baseline through Day 28
|
|
Proportion of Subjects With Sustained Response From Day 2 Through Day 28
기간: Day 2 through Day 28
|
Subjects achieving sustained response, defined as a ≥50% reduction from Baseline in MADRS total score, with onset by Day 2 and maintained through the end of the double-blind treatment period. |
Day 2 through Day 28
|
|
Proportion of Subjects With Clinical Global Impression of Improvement (CGI-I) Score of 1 or 2 at Scheduled Postbaseline Visits
기간: Up to Day 28
|
The CGI-I is a clinician-rated assessment of change in illness relative to Baseline. Scores range from 1 (very much improved) to 7 (very much worse). This outcome evaluates subjects with a score of 1 (very much improved) or 2 (much improved). |
Up to Day 28
|
공동 작업자 및 조사자
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACP-211-002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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