Boston, Massachusetts 02114


Purpose:

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 summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

2007-P-000731


NCT ID:

NCT00575666


Secondary ID:


Study Acronym:


Brief Title:

Intranasal Insulin Treatment in Patients With Schizophrenia


Official Title:

Intranasal Insulin Treatment in Patients With Schizophrenia


Overall Status:

Recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Xiaoduo Fan, M.D.
Principal Investigator
Massachusetts General Hospital
Primary Contact:Karina Tsatourian, Ph.D.
617-912-7837
Backup Contact:Ju Hyung Park, BA
617-912-7848
jpark24@partners.org

Study Dates

Start Date:December 2007
Completion Date:June 2010
Completion Type:Anticipated
Primary Completion Date:June 2010
Primary Completion Type:Anticipated
Verification Date:February 2010
Last Changed Date:February 9, 2010
First Received Date:December 14, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:cognitive function and psychopathology
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:insulin
Description:intranasal insulin 40IU 4 times per day
Arm Name:A

Study Arms

Study Arm Type:Experimental
Arm Name:A
Description:Intranasal insulin treatment
Study Arm Type:No Intervention
Arm Name:B

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital
Agency Class:Other
Agency Type:Collaborator
Agency Name:National Alliance for Research on Schizophrenia and Depression

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.