Intranasal Insulin Treatment in Patients With Schizophrenia
2012년 11월 15일 업데이트: Xiaoduo Fan, University of Massachusetts, Worcester
This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia subjects to examine insulin's effect on psychopathology and cognition.
In addition, the study will examine insulin's effects on weight, food intake, resting energy expenditure, and body composition.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The specific aims include:
Primary aims
- Examine the efficacy of intranasal regular insulin (40 IU 4 times per day) in improving cognitive deficits in patients with schizophrenia.
- Examine the efficacy of intranasal regular insulin in improving negative symptoms and positive symptoms of schizophrenia.
Secondary aims
- Examine intranasal insulin's effects on weight, food intake and resting energy expenditure.
- Examine intranasal insulin's effects on body composition, waist circumference, and waist/hip ratio.
연구 유형
연구 유형
중재적
등록 (실제)
등록
45
단계
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Massachusetts
-
Worcester, Massachusetts, 미국, 01605
- University of Massachusetts Medical School
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age 18-65 years.
- Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype.
- Stable dose of the current antipsychotic drug for at least one month.
- Well established compliance with outpatient treatment per treating clinician's judgement.
- 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 (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.
Exclusion Criteria:
- Inability to provide informed consent.
- Current substance abuse.
- Psychiatrically unstable per treating clinician's judgement.
- Significant medical illnesses including uncontrolled hypertension, diabetes, seizure. disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases.
- Pregnancy or breastfeeding.
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
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
위약 비교기: 비
약물: 위약
|
intranasal, 40IU, 4 times daily
|
|
실험적: A
Intranasal Insulin Treatment
|
intranasal, 40IU, 4 times daily
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cognitive Function- Digit Span Total
기간: Week 8
|
Subjects completed the digit span task.
Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology.
Min score= 0, Max score= 30.
Week 8 values are displayed below.
|
Week 8
|
|
Cognitive Function- Verbal Fluency
기간: Week 8
|
Subjects completed a verbal fluency test.
Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology.
Min score= 0, Max score= N/A.
Week 8 values are displayed below.
|
Week 8
|
|
Cognitive Function- HVLT Immediate Recall Total
기간: Week 8
|
Subjects completed a word recall task.
Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology.
Min score= 0, Max score= 36.
Week 8 values are displayed below.
|
Week 8
|
|
Cognitive Function- HVLT Delayed Recall Total
기간: Week 8
|
Subjects completed a delayed word recall task.
Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology.
Min score= 0, Max score= 12. Week 8 values are displayed below.
|
Week 8
|
|
Cognitive Function- Trails A
기간: Week 8
|
Subjects completed a timed "trails" (i.e.
connect-the-dots) test.
Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds.
Max score= N/A.
Lower values represent less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Cognitive Function- Trails B
기간: Week 8
|
Subjects completed a timed "trails" (i.e.
connect the dots) test.
Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds.
Max score= N/A.
Lower values represent less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Cognitive Function- CPT D Prime Score
기간: Week 8
|
Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus over a period of several minutes) before and after intranasal treatment.
During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen.
The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks.
Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits.
False alarms were also recorded.
The "d prime score" is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured.
A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity.
Values below represent postreatment performance minus pretreatment performance.
Higher scores represent less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Cognitive Function- CPT Hits Rate (Proportion)
기간: Week 8
|
Subjects completed a computer-based cognitive test.
The test is described in detail in a previous outcome measure ("CPT d prime score").
Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits).
Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured.
Min score= 0, Max score= 1.0.
Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
기간: Week 8
|
Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes).
The test is described in detail in a previous outcome measure ("CPT d prime score").
Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli.
Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds.
Max score= N/A.
Lower values represent less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Cognitive Function- CPT False-alarm Rate (Proportion)
기간: Week 8
|
Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes).
False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets).
Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits.
Min score= 0, Max score= 1.0.
Lower values represent higher hit accuracy and less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Psychopathology- PANSS Total
기간: Week 8
|
Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8.
The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme).
Min score= 30, Max score= 210.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Psychopathology- PANSS Positive
기간: Week 8
|
Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8.
The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme).
Min score= 7, Max score= 49.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Psychopathology- PANSS Negative
기간: Week 8
|
Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme).
Min score= 7, Max score= 49.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Psychopathology- PANSS General Psychopathology
기간: Week 8
|
General psychopathology was measured at Screening/Baseline, Week 4, and Week 8.
The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme).
Min score= 16, Max score= 112.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Psychopathology- SANS Total
기간: Week 8
|
Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe).
Min score= 0, Max score= 125.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Psychopathology- CDSS Total
기간: Week 8
|
Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe).
Min score= 0, Max score= 27.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
|
Psychopathology- QLS Total
기간: Week 8
|
Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present).
Min score= 0, Max score= 126.
Higher scores represent lower quality of life.
Week 8 values are displayed below.
|
Week 8
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Xiaoduo Fan, MD, MPH, MS, UMass Medical School
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
연구 시작
2007년 12월 1일
기본 완료 (실제)
기본 완료
2010년 9월 1일
연구 완료 (실제)
연구 완료
2010년 9월 1일
연구 등록 날짜
최초 제출
최초 제출
2007년 12월 14일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2007년 12월 14일
처음 게시됨 (추정)
처음 게시됨
2007년 12월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
마지막 업데이트 게시됨
2012년 12월 17일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2012년 11월 15일
마지막으로 확인됨
마지막으로 확인됨
2012년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2007-P-000731
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. .
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