이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia (VECTOR)

2015년 9월 29일 업데이트: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Three Fixed Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

연구 유형

중재적

등록 (실제)

636

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 대한민국
      • Incheon, 대한민국, 405-760
      • Incheon, 대한민국, 400-711
      • Seoul, 대한민국, 136-705
      • Seoul, 대한민국, 137-710
      • Seoul, 대한민국, 143-711
  • 라트비아
      • Daugavpils, 라트비아, LV-5417
      • Jelgava, 라트비아, LV-3008
      • Liepaja, 라트비아, LV-3401
      • Riga, 라트비아, LV-1005
      • Strenci, 라트비아, LV-4730
  • 루마니아
      • Arad, 루마니아, 310022
      • Bucuresti, 루마니아, 010825
      • Bucuresti, 루마니아, 041914
      • Bucuresti, 루마니아, 030442
      • Cluj-Napoca, 루마니아, 400012
      • Focsani, 루마니아, 620165
      • Pitesti, 루마니아, 110069
      • Targoviste, 루마니아, 130086
  • 미국
    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
    • California
      • Garden Grove, California, 미국, 92845
      • Glendale, California, 미국, 91206
      • Oakland, California, 미국, 94612
      • Oceanside, California, 미국, 92056
      • San Diego, California, 미국, 92123
      • San Diego, California, 미국, 92102
    • Florida
      • Bradenton, Florida, 미국, 34208
      • Miami Springs, Florida, 미국, 33166
      • Orlando, Florida, 미국, 32806
    • New York
      • Fresh Meadows, New York, 미국, 11423
      • Jamaica, New York, 미국, 11432
    • Ohio
      • Dayton, Ohio, 미국, 45417
    • South Carolina
      • Charleston, South Carolina, 미국, 29407
      • Charleston, South Carolina, 미국, 29405
    • Texas
      • Austin, Texas, 미국, 78754
    • Washington
      • Kirkland, Washington, 미국, 98033
  • 세르비아
      • Belgrade, 세르비아, 11000
      • Kragujevac, 세르비아, 34000
      • Novi Sad, 세르비아, 21000
  • 우크라이나
      • Chernihiv, 우크라이나, 14000
      • Dnipropetrovsk, 우크라이나, 49005
      • Dnipropetrovsk, 우크라이나, 49115
      • Glevakha, 우크라이나, 08631
      • Kherson, Vil. Stepanivka, 우크라이나, 73488
      • Kyiv, 우크라이나, 02660
      • Kyiv, 우크라이나, 04080
      • Lviv, 우크라이나, 79021
      • Simferopol, 우크라이나, 95006
      • Vinnytsia, 우크라이나, 21005
  • 일본
      • Kumamoto-shi, 일본, 861-8002
    • Kanagawa-Ken
      • Fujisawa-shi, Kanagawa-Ken, 일본, 251-8530
    • Okinawa-Ken
      • Kunigami-gun, Okinawa-Ken, 일본, 904-1201
    • Osaka-Fu
      • Sakai-shi, Osaka-Fu, 일본, 590-0018
    • Tokyo-To
      • Setagaya-ku, Tokyo-To, 일본, 156-0057
  • 캐나다
    • Ontario
      • Burlington, Ontario, 캐나다, L7R 4E2
      • Chatham, Ontario, 캐나다, N7M 5L9
      • Chatham, Ontario, 캐나다, N7L 1B7
  • 폴란드
      • Choroszcz, 폴란드, 16-070
      • Gdansk, 폴란드, 80-952
      • Gdansk, 폴란드, 80-282
      • Lodz, 폴란드, 91-229

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:

  1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
  2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
  3. Subjects experiencing an acute exacerbation of psychotic symptoms
  4. Other protocol specific inclusion criteria may apply

Exclusion Criteria:

  1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug

  2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

    • Schizoaffective disorder
    • Major depressive disorder (MDD)
    • Bipolar disorder
    • Delirium, dementia, amnestic or other cognitive disorder
    • Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
  3. Subjects presenting with a first episode of schizophrenia
  4. Other protocol specific exclusion criteria may apply

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
위약, 매일 1회, 6주 동안
의약품: 위약
위약, 매일 1회, 6주 동안
실험적: OPC-34712 [Brexpiprazole] High Dose
Higher Dose, tablet, once daily, for six weeks
의약품: OPC-34712 [Brexpiprazole] High Dose
Higher dose, tablet, once daily, for six weeks
실험적: OPC-34712 [Brexpiprazole] Middle Dose
Middle Dose, tablet, once daily, for six weeks
의약품: Experimental: OPC-34712 [Brexpiprazole] Middle Dose
Middle dose, tablet, once daily, for six weeks
실험적: OPC-34712 [Brexpiprazole] Low Dose
Lower Dose, tablet, once daily, for six weeks
의약품: Experimental: OPC-34712 [Brexpiprazole] Low Dose
Lower dose, tablet, once daily, for six weeks

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.
기간: Baseline to Week 6
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Baseline to Week 6

2차 결과 측정

결과 측정
측정값 설명
기간
Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
기간: Baseline to Week 6
The severity of illness was rated using the CGI-S which is the key secondary endpoint. To perform this assessment, the rater or study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant.
Baseline to Week 6
Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.
기간: Baseline to Week 1, 2, 3, 4, 5
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Baseline to Week 1, 2, 3, 4, 5
Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
기간: Baseline to Week 1, 2, 3, 4 and 5
The severity of illness was rated using the CGI-S. To perform this assessment, the rater or study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant.
Baseline to Week 1, 2, 3, 4 and 5
Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)
기간: Baseline to Week 6
The PSP is a clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Baseline to Week 6
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score
기간: Baseline to Week 6
For each symptom construct of the PANSS Positive Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score
기간: Baseline to Week 6
For each symptom construct of the PANSS Negative Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6
기간: Week 6
The participant's overall improvement was rated using the CGI-I. The rater or study physician rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared with the participant's condition at screening/baseline. Response choices were: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.
Week 6
Response Rate at Week 6
기간: Week 6
Response rate was defined as improvement in mean change of ≥30% from baseline in PANSS Total Score at Week 6 or CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6.
Week 6
Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score
기간: Baseline to Week 6
The PEC consists of 5 PANSS items (excitement [P4], hostility [P7], tension [G4], uncooperativeness [G8], and poor impulse control [G14]). Each rated on a scale of 1 (absent) to 7 (extreme). The PEC for participants was calculated as the sum of the rating assigned to each of the 5 items, and ranged from 5 to 35 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Discontinuation Rate for Lack of Efficacy at Week 6
기간: Week 6
Week 6
Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score
기간: Baseline to Week 6
The PANSS Marder Factor score - Positive Symptoms Score consists of 8 PANSS items (delusions [P1], hallucinatory behaviour [P3], grandiosity [P5], suspiciousness [P6], stereotyped thinking [N7], somatic concern [G1], unusual thought content [G9], lack of judgment and insight [G10]. Each was rated on a scale of 1 (absent) to 7 (extreme). The PANSS Marder Factor score - Positive Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 8 items, and ranged from 8 to 42 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score
기간: Baseline to Week 6
The PANSS Marder Factor score - Negative Symptoms Score consists of 7 PANSS items (blunted effect [N1], emotional withdrawal [N2], poor rapport [N3], passive/apathetic social withdrawal [N4], lack of spontaneity and conversation flow [N6], motor retardation [G7], active social avoidance [G16]). The PANSS Marder Factor score - Negative Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score
기간: Baseline to Week 6
The PANSS Marder Factor score -Disorganized Thought Score consists of 7 PANSS items (conceptual disorganization [P2], difficulty in abstract thinking [N5], mannerisms and posturing [G5], disorientation [G10], poor attention [G11], disturbance of violation [G13], preoccupation [G15]). The PANSS Marder Factor score - Disorganized Thought Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score
기간: Baseline to Week 6
The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score consists of 4 PANSS items (excitement [P4], hostility [P7], uncooperativeness [G8], poor impulse control [G14]). The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score
기간: Baseline to Week 6
The PANSS Marder Factor score - Anxiety/Depression Score consists of 4 PANSS items (anxiety [G2], guilt feelings [G3], tension [G4], depression [G6]). The PANSS Marder Factor score - Anxiety/Depression Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.
Baseline to Week 6

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Otsuka Pharmaceutical Development & Commercialization, Inc.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2011년 7월 1일

기본 완료 (실제)

2014년 1월 1일

연구 완료 (실제)

2014년 1월 1일

연구 등록 날짜

최초 제출

2011년 7월 11일

QC 기준을 충족하는 최초 제출

2011년 7월 15일

처음 게시됨 (추정)

2011년 7월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 10월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 9월 29일

마지막으로 확인됨

2015년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 331-10-231

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. .

구독하다