View Clinical Trial (Medical Research Study)
Intranasal Insulin Treatment in Patients With Schizophrenia
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Schizophrenia |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00575666 |
| Primary Contact: |
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Principal Investigator
Xiaoduo Fan, M.D.
Massachusetts General Hospital
Karina Tsatourian, Ph.D.
Phone: 617-912-7837
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| Backup Contact: |
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Email: jpark24@partners.org
Ju Hyung Park, BA
Phone: 617-912-7848
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| Location Contact: |
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Boston, Massachusetts 02114
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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