Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors
Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study
연구 개요
상세 설명
This was a double-blind placebo controlled study of varenicline and matched placebo in patients with a diagnosis of schizophrenia or schizoaffective psychosis who were treated with antipsychotic medication and were cigarette smokers. Three sites (2 U.S., 1 Israel) were supported by the Stanley grant. A similar independently supported study was conducted in Beijing, China. We were allowed to access these data and combine them for our analysis of results. Subjects at each site participated in a protocol which was approved by their institutional IRB. All subjects signed informed consent.
The study evaluated multiple measures of cigarette smoking, cognitive functions by MATRICS battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia), and psychiatric symptoms by PANSS (Positive and Negative Symptom Scale), SANS (Schedule For Assessment Of Negative Symptoms), and Calgary Depression scales. Lymphocytes were collected for measurement of epigenetically related mRNA's.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10035
- Manhattan Psychatirc Center
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Orangeburg, New York, 미국, 10962
- Nathan Kline Insitute for Psychiatric Research
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Tel Hashomer, 이스라엘, 52621
- The Division of Psychiatry, Chaim Sheba Medical Center
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Beijing, 중국, 100191
- Peking University Institute of Mental Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication
Exclusion Criteria:
prior history of hospitalization for acute myocardial infarction or stroke, or persistent angina pectoris with current symptoms Patients who have previously tried varenicline and have stopped taking it because of side-effects of severe nausea or vomiting suicide attempt in the last year and or have had prominent or serious suicidal thoughts in the past year Women who are pregnant, nursing, or unable to use reliable contraception significant renal impairment(Creatinine ≥ 1.5) baseline Hamilton Depression Scores is >20
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Varenicline
Varenciline 1-2 mg/day
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Varenicline 1-2 mg/day
다른 이름들:
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위약 비교기: Matched Placebo
placebo for varenicline
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Placebo
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cotinine Level
기간: Baseline, 4 weeks, 8 weeks
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plasma cotinine
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Baseline, 4 weeks, 8 weeks
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Change From Baseline in Cognitive Performance
기간: basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks)
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The MATRICS Consensus Cognitive Battery (MCCB)(Measurement and Treatment Research to Improve Cognition in Schizophrenia) was used to measure cognitive performance.
Six Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program (modified beta version) from raw scores on 10 individually administered subtests.
The social cognition test was not assessed in this study.
The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile).
The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile).
Higher scores after baseline represent better outcomes.
Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.
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basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Psychiatric Symptoms
기간: baseline, 4 weeks, 8 weeks
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The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms.
Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96).
All three subscales were summed for the PANSS total score (total scale range: 30-180).
Scores closer to 30 after baseline represented better outcomes.
Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.
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baseline, 4 weeks, 8 weeks
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Change From Basellne in Calgary Depression Scale Score
기간: baseline, 4 weeks, 8 weeks
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The Calgary Depression Scale for Schizophrenia.
The scale has 9 items with ratings of 0 to 3 on each item.
Total score can vary from 0 to 27.
Higher scores indicate more depression.
Negative change scores indicate decreasing depression.
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baseline, 4 weeks, 8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robert C. Smith, MD, PhD, Nathan Kline Institute for Psychiatric Research
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- 081/C02
- FDA IND 102,411
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. .
Varenicline에 대한 임상 시험
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University of PennsylvaniaNational Cancer Institute (NCI); Northwestern University모병
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Thomas Jefferson University모집하지 않고 적극적으로