- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01578486
Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15 schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive functioning, and metabolic parameters.
Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 15 subjects will be enrolled.
연구 개요
상세 설명
The specific aims include:
Primary aims:
- Examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS).
- Examine the efficacy of salsalate in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score.
Secondary aims:
1. Examine salsalate's effects on inflammatory markers such as high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Massachusetts
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Worcester, Massachusetts, 미국, 01605
- University of Massaschusetts Medical School
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18-65 years;
- Diagnosis of schizophrenia or schizoaffective disorder;
- Stable dose of the current antipsychotic drug for at least one month;
- Well established compliance with outpatient treatment per treating clinician's judgment;
- Able to complete the cognitive assessment battery (must be English speaking);
- Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.
Exclusion Criteria:
- Inability to provide informed consent;
- Current substance abuse;
- Psychiatrically unstable per treating clinician's judgment;
- Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases;
- Currently on immunosuppressant medication including oral steroids;
- Use of anti-coagulants (heparin, LMWH, warfarin, cilostazol, clopidogrel, dabigatran);
- History of chronic infection (including, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition;
- Experienced asthma, urticaria or allergic type reaction after taking aspirin, salsalate, or other NSAIDS;
- Pregnancy or breastfeeding;
- Pre-existing chronic tinnitus.
- Known hypersensitivity to salsalate.
공부 계획
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 |
|---|---|
|
실험적: salsalate
open-label trial of salsalate 3g/day
|
open-label trial of salsalate 3g/day for 12 weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
PANSS Total Score
기간: Baseline and 12 weeks
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Positive and negative symptoms of schizophrenia will be measured by total score on all subscales of the Positive and Negative Syndrome Scale (PANSS; score range 30-210).
Higher scores correspond with worse outcomes.
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Baseline and 12 weeks
|
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SANS Total Score
기간: Baseline, 12 weeks
|
Negative symptoms of schizophrenia will be measured by total score on the Scale for Assessment of Negative Symptoms (SANS; score range 0-100).
Higher scores correspond with worse outcomes.
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Baseline, 12 weeks
|
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MATRICS Composite Score
기간: Baseline, 12 weeks
|
Improved cognition will be measured using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment.
The MATRICS assessment includes a battery of tests, and the composite t-score measures cognition across 7 domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition.
A higher score indicates better cognition.
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Baseline, 12 weeks
|
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PANSS Positive Score
기간: Baseline, 12 weeks
|
Subscale of Positive and Negative Syndrome Scale that specifically measures positive symptoms.
The scores range from 7-49, with higher scores representing a worse outcome.
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Baseline, 12 weeks
|
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PANSS- Negative Score
기간: Baseline, 12 weeks
|
Subscale of Positive and Negative Syndrome Scale that specifically measures negative symptoms.
The scores range from 7-49, with higher scores representing a worse outcome.
|
Baseline, 12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hs-CRP
기간: Baseline, 12 weeks
|
High-sensitivity C-reactive protein (hs-CRP) will be measured in mg/L in order to detect inflammation.
Higher hs-CRP values correspond to higher levels of inflammation.
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Baseline, 12 weeks
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TNF-alpha
기간: Baseline,12 weeks
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Tumor necrosis-alpha factor will be measured to assess inflammation levels.
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Baseline,12 weeks
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IL-6
기간: Baseline, week 12
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IL-6 (interleukin 6) is a marker used to measure inflammation.
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Baseline, week 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Xiaoduo Fan, MD, MPH, MS, UMass Medical School
- 연구 책임자: Matthew R Goodnow, BS, UMass Medical School
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
- 2011-P-000798
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