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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
45
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Massachusetts
-
Worcester、Massachusetts、アメリカ、01605
- University of Massachusetts Medical School
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：B
薬: プラセボ
|
intranasal, 40IU, 4 times daily
|
|
実験的：A
Intranasal Insulin Treatment
|
intranasal, 40IU, 4 times daily
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cognitive Function- Digit Span Total
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Xiaoduo Fan, MD, MPH, MS、UMass Medical School
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年12月1日
一次修了 (実際)
2010年9月1日
研究の完了 (実際)
2010年9月1日
試験登録日
最初に提出
2007年12月14日
QC基準を満たした最初の提出物
2007年12月14日
最初の投稿 (見積もり)
2007年12月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年12月17日
QC基準を満たした最後の更新が送信されました
2012年11月15日
最終確認日
2012年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2007-P-000731
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Insulin or Placeboの臨床試験
-
Anne Louise Tølbøll Sørensenまだ募集していません
-
Chesapeake Eyecare and Laser Center, LLCCarl Zeiss Meditec, Inc.完了
-
Shanghai Hengrui Pharmaceutical Co., Ltd.完了