Intranasal Insulin Treatment in Patients With Schizophrenia
Completed · Phase 4 · Has a placebo group
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT00575666
- Run by
- University of Massachusetts, Worcester
- People needed
- 45
- Starts
- 2007-12-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2012-12-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Massachusetts Medical School — Worcester, Massachusetts, United States
Full record on ClinicalTrials.gov
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