Clinical trial NCT00575666: Intranasal Insulin Treatment in Patients With Schizophrenia
Official title: Intranasal Insulin Treatment in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: cognition, psychopathology
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
name: Eli Lilly and Company
First posted: 2007-12-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Cognitive Function- Digit Span Total
timeFrame: Week 8
measure: Cognitive Function- Verbal Fluency
timeFrame: Week 8
measure: Cognitive Function- HVLT Immediate Recall Total
timeFrame: Week 8
measure: Cognitive Function- HVLT Delayed Recall Total
timeFrame: Week 8
measure: Cognitive Function- Trails A
timeFrame: Week 8
measure: Cognitive Function- Trails B
timeFrame: Week 8
measure: Cognitive Function- CPT D Prime Score
timeFrame: Week 8
measure: Cognitive Function- CPT Hits Rate (Proportion)
timeFrame: Week 8
measure: Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
timeFrame: Week 8
measure: Cognitive Function- CPT False-alarm Rate (Proportion)
timeFrame: Week 8
measure: Psychopathology- PANSS Total
timeFrame: Week 8
measure: Psychopathology- PANSS Positive
timeFrame: Week 8
measure: Psychopathology- PANSS Negative
timeFrame: Week 8
measure: Psychopathology- PANSS General Psychopathology
timeFrame: Week 8
measure: Psychopathology- SANS Total
timeFrame: Week 8
measure: Psychopathology- CDSS Total
timeFrame: Week 8
measure: Psychopathology- QLS Total
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Xiaoduo Fan, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: