- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00575666
Intranasal Insulin Treatment in Patients With Schizophrenia
November 15, 2012 updated by: 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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- University of Massachusetts Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: B
Drug: Placebo
|
intranasal, 40IU, 4 times daily
|
Experimental: A
Intranasal Insulin Treatment
|
intranasal, 40IU, 4 times daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Function- Digit Span Total
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiaoduo Fan, MD, MPH, MS, UMass Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 18, 2007
Study Record Updates
Last Update Posted (Estimate)
December 17, 2012
Last Update Submitted That Met QC Criteria
November 15, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-P-000731
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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