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Intranasal Insulin Treatment in Patients With Schizophrenia

NCT ID: NCT00575666

Last Updated: 2012-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Keywords

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cognition, psychopathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Intranasal Insulin Treatment

Group Type EXPERIMENTAL

Insulin or Placebo

Intervention Type DRUG

intranasal, 40IU, 4 times daily

B

Drug: Placebo

Group Type PLACEBO_COMPARATOR

Insulin or Placebo

Intervention Type DRUG

intranasal, 40IU, 4 times daily

Interventions

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Insulin or Placebo

intranasal, 40IU, 4 times daily

Intervention Type DRUG

Eligibility 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Xiaoduo Fan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoduo Fan, MD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Locations

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University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2007-P-000731

Identifier Type: -

Identifier Source: org_study_id