Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
2014년 4월 29일 업데이트: Takeda
A Phase 3, Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 (15 and 20 mg) in Subjects With Major Depressive Disorder
The purpose of this study is to determine the long-term safety and tolerability of vortioxetine, once daily (QD), in participants with major depressive disorder.
연구 개요
상세 설명
Depression has been recognized as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder (MDD) is among the most important causes of disability worldwide, in both developing and developed countries. Major depressive disorder is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. Major depressive disorder is characterized by the presence of 1 or more major depressive episodes that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration.
This is a multicenter extension study designed to allow eligible patients who have completed short-term efficacy and safety studies LuAA21004_315 (NCT01153009), LuAA21004_316 (NCT01163266) and LuAA21004_317 (NCT01179516) to receive the 52-week treatment with vortioxetine in this open-label extension study. Participants are expected to return to the site for approximately 13 visits.
A safety follow-up call will be made 4 weeks after completion of the 52-week treatment period.
연구 유형
중재적
등록 (실제)
1075
단계
- 3단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Has completed either study LuAA21004_315 ( NCT01153009), LuAA21004_316 (NCT01163266), or LuAA21004_317 (NCT01179516) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the Week 8 [Lu AA21004_317] or Week 10 [Lu AA21004_315 or Lu AA21004_316] assessment of the preceding protocol).
- Suffers from a recurrent major depressive episode) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) at entry into the prior study.
- Twelve-month continuation treatment with Lu AA21004 is indicated for the treatment of this participant according to the opinion of the investigator.
- Females of childbearing potential who are sexually active with a nonsterilized male partner agree to routinely use adequate contraception throughout the duration of the study.
Exclusion Criteria:
- Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
- In the investigator's clinical judgment, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS).
- In the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
- Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
- Has used/uses disallowed concomitant medication.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Vortioxetine
Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
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보티옥세틴 정제
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%
기간: Over the 52 week period
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Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug.
A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
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Over the 52 week period
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Number of Participants With Serious Treatment-Emergent Adverse Events
기간: Over the 52 week period
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Serious treatment-emergent adverse events (serious-TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug.
A serious-TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Other important medical events, based upon appropriate medical judgment, may also be considered serious adverse events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
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Over the 52 week period
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Treatment-Emergent Adverse Events Leading to Study Discontinuation
기간: Over the 52 week period
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Treatment-emergent adverse events are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug.
A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
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Over the 52 week period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
기간: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44, and 52
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The change between MADRS total score at each assessed visit and MADRS score at baseline.
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.
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Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44, and 52
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
기간: Baseline and Weeks 4, 24, and 52
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The change between HAM-A score at each assessed visit and HAM-A score at baseline.
HAM-A is a 14 item rating scale to quantify anxiety symptomatology severity (i.e., anxious mood, tension, fear, insomnia, etc.) rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56.
Higher scores indicate greater severity of symptoms.
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Baseline and Weeks 4, 24, and 52
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Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
기간: Baseline and Weeks 4, 24, and 52
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The change between CGI-S score at each assessed visit and CGI-S score at baseline.
The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?"
which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill).
Higher scores indicate greater severity of illness.
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Baseline and Weeks 4, 24, and 52
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score
기간: Baseline and Weeks 12, 24, 36, and 52
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The change between the SDS total score at each assessed visit and the total score collected at baseline.
The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30.
Higher scores indicate greater severity of impairment.
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Baseline and Weeks 12, 24, 36, and 52
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Change From Baseline in SDS Work/School Subscale
기간: Baseline and Weeks 12, 24, 36, and 52
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The change between the Sheehan Disability work/school subscale score at each assessed visit and work/school subscale score collected at baseline.
The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely).
Higher scores indicate greater severity of impairment.
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Baseline and Weeks 12, 24, 36, and 52
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Change From Baseline in SDS Social Life Subscale
기간: Baseline and Weeks 12, 24, 36, and 52
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The change between the Sheehan Disability social life subscale score at each assessed visit and social life subscale score collected at baseline.
The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely).
Higher scores indicate greater severity of impairment.
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Baseline and Weeks 12, 24, 36, and 52
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Change From Baseline in SDS Family Life/Home Responsibilities Subscale
기간: Baseline and Weeks 12, 24, 36, and 52
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The change between the Sheehan Disability family life/home responsibilities subscale score at each assessed visit and family life/home responsibilities subscale score collected at baseline.
The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely).
Higher scores indicate greater severity of impairment.
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Baseline and Weeks 12, 24, 36, and 52
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Senior Medical Director, Takeda
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 9월 1일
기본 완료 (실제)
2013년 5월 1일
연구 완료 (실제)
2013년 5월 1일
연구 등록 날짜
최초 제출
2010년 6월 28일
QC 기준을 충족하는 최초 제출
2010년 6월 28일
처음 게시됨 (추정)
2010년 6월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 5월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 4월 29일
마지막으로 확인됨
2014년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- LuAA21004_314
- U1111-1115-4927 (레지스트리 식별자: WHO)
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. .