Intranasal Insulin Treatment in Patients With Schizophrenia

University of Massachusetts, Worcester

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Insulin or Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00575666

2007-P-000731

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Intranasal Insulin Treatment

Treatment:

Drug: Insulin or Placebo

B

Placebo Comparator group

Description:

Drug: Placebo

Treatment:

Drug: Insulin or Placebo