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Intranasal Insulin Treatment in Patients With Schizophrenia

2012年11月15日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The specific aims include:

Primary aims

  1. Examine the efficacy of intranasal regular insulin (40 IU 4 times per day) in improving cognitive deficits in patients with schizophrenia.
  2. Examine the efficacy of intranasal regular insulin in improving negative symptoms and positive symptoms of schizophrenia.

Secondary aims

  1. Examine intranasal insulin's effects on weight, food intake and resting energy expenditure.
  2. Examine intranasal insulin's effects on body composition, waist circumference, and waist/hip ratio.

研究类型

介入性

注册 (实际的)

45

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Massachusetts
      • Worcester、Massachusetts、美国、01605
        • University of Massachusetts Medical School

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age 18-65 years.
  2. Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype.
  3. Stable dose of the current antipsychotic drug for at least one month.
  4. Well established compliance with outpatient treatment per treating clinician's judgement.
  5. Able to complete the cognitive assessment battery (must be English speaking).
  6. 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:

  1. Inability to provide informed consent.
  2. Current substance abuse.
  3. Psychiatrically unstable per treating clinician's judgement.
  4. Significant medical illnesses including uncontrolled hypertension, diabetes, seizure. disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases.
  5. Pregnancy or breastfeeding.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：乙
药物：安慰剂
药品：Insulin or Placebo
intranasal, 40IU, 4 times daily
实验性的：A
Intranasal Insulin Treatment
药品：Insulin or Placebo
intranasal, 40IU, 4 times daily

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Cognitive Function- Digit Span Total
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Massachusetts, Worcester

合作者

Eli Lilly and Company
National Alliance for Research on Schizophrenia and Depression

调查人员

  • 首席研究员：Xiaoduo Fan, MD, MPH, MS、UMass Medical School

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年12月1日

初级完成 (实际的)

2010年9月1日

研究完成 (实际的)

2010年9月1日

研究注册日期

首次提交

2007年12月14日

首先提交符合 QC 标准的

2007年12月14日

首次发布 (估计)

2007年12月18日

研究记录更新

最后更新发布 (估计)

2012年12月17日

上次提交的符合 QC 标准的更新

2012年11月15日

最后验证

2012年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2007-P-000731

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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