- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00646581
Effect of Single Dose Intranasal Insulin On Cognitive Function
Effect of Single Dose Intranasal Insulin on Cognitive Function in Patients With Schizophrenia
The purpose of the study is to find out how a small dose of insulin might affect memory, the ability to concentrate, and improve your daily functioning in patients with schizophrenia and schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's effect on cognition. The specific aims include:
- Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on cognitive functioning, including attention and memory.
- Examine whether single dose of intranasal insulin administration will raise serum insulin level and decrease plasma glucose level
Insulin will be delivered through an air spray pump into your nose. The investigators will be comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02114
- Freedom Trail Clinic
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age 18-65 years
- Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype
- Male or female
- Stable dose of the current antipsychotic drug for at least one month
- Well established compliance with out-patient treatment per treating clinician's judgement.
- Able to complete the cognitive assessment battery (must be English speaking)
Exclusion Criteria:
- Inability to provide informed consent
- Current substance abuse
- On clozapine or olanzapine
- Psychiatrically unstable per treating clinician's judgement.
- Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases etc.
- Incapable to complete the cognitive battery assessment.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Плацебо Компаратор: Placebo (1)
Subjects are given a one-time, single dose of placebo intranasal spray
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Плацебо
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Экспериментальный: Single-Dose Intranasal Insulin
Subjects are given a one-time, single dose of intranasal insulin
|
40 IU Intranasal Insulin will be administered once
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)
Временное ограничение: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Subjects performed the HVLT Immediate Recall Task.
For this task, participants were read aloud a list of 12 words from three taxonomic categories.
Participants were read the list three separate times, and after each reading were immediately asked to recall as many words from the list as they could.
The number of words recalled successfully was measured before and after intranasal treatment.
Values below represent posttreatment performance minus pretreatment performance.
|
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Improvement in Cognitive Function- HVLT-Delayed Recall (Number)
Временное ограничение: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Subjects performed the HVLT word recall task after a 20-minute delay before and after intranasal treatment.
In the HVLT delayed recall task, participants were asked to recall the same list of 12 words dictated in the immediate recall task 20 minutes after the completion of the immediate recall task.
Words successfully recalled after the 20-minute delay were measured.
Values below represent posttreatment performance minus pretreatment performance.
|
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
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CPT d Score
Временное ограничение: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Subjects performed a computer-based test designed to measure sustained attention (attention to a specific stimuli 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.
|
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Improvement in Cognitive Function- CPT Hits Rate (Proportion)
Временное ограничение: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment.
The task is described in the previous outcome measure ("CPT d score").
Hits rate refers to each participant's ability to correctly respond to two consecutive target presentations (i.e.
correct responses).
Hits rate was measured as a proportion of overall attempts (0= no hits, 1.0= 100% accuracy on hits).
Values below represent posttreatment performance minus pretreatment performance.
|
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
Временное ограничение: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment.
The task is described in detail in a previous outcome measure ("CPT d score").
Reaction time of hits refers to the average time each participant took to correctly respond to a stimuli in milliseconds.
Values below represent posttreatment performance minus pretreatment performance.
|
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)
Временное ограничение: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment.
The task is described in detail in a previous outcome measure ("CPT d score").
False alarm rate refers to the proportion of overall attempts that were characterized as incorrect responses (responses to two non-identical targets).
Values below represent posttreatment performance minus pretreatment performance.
|
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
|
Соавторы и исследователи
Следователи
- Главный следователь: Xiaoduo Fan, MD, MPH, MS, UMass Medical School
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 4-2006
- CORRC tracking number: 4-2006
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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