Intranasal Insulin Treatment in Patients With Schizophrenia

This study is currently recruiting participants.

Verified by Massachusetts General Hospital, February 2009

First Received: December 14, 2007 Last Updated: February 9, 2009 History of Changes

Sponsors and Collaborators:	Massachusetts General Hospital National Alliance for Research on Schizophrenia and Depression
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00575666

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. 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.

Condition	Intervention	Phase
Schizophrenia	Drug: insulin	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Intranasal Insulin Treatment in Patients With Schizophrenia

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

cognitive function and psychopathology [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Intranasal insulin treatment	Drug: insulin intranasal insulin 40IU 4 times per day
B: No Intervention

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575666

Contacts

Contact: Karina Tsatourian, Ph.D.

617-912-7837

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Xiaoduo Fan, M.D.

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachussetts General Hospital ( Xiaoduo Fan )
Study ID Numbers:	2007-P-000731/3
Study First Received:	December 14, 2007
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00575666 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

cognition, psychopathology

Study placed in the following topic categories:

Schizophrenia
Hypoglycemic Agents
Mental Disorders

Psychotic Disorders
Insulin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Hypoglycemic Agents
Mental Disorders
Physiological Effects of Drugs

Pharmacologic Actions
Insulin
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009