Overview

Intranasal Insulin Treatment in Patients With Schizophrenia

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Massachusetts, Worcester
Collaborators:
Eli Lilly and Company
National Alliance for Research on Schizophrenia and Depression
Treatments:
Insulin
Insulin, Globin Zinc
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.