Phase 4
N=45
Intranasal Insulin Treatment in Patients With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00575666 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Cognitive Function- Digit Span Total — 13.3; 14.1 Items correct
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin or Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Function- Digit Span Total |
13.3; 14.1 | — |
| PRIMARY Cognitive Function- Verbal Fluency |
27.9; 28.0 | — |
| PRIMARY Cognitive Function- HVLT Immediate Recall Total |
21.4; 23.6 | — |
| PRIMARY Cognitive Function- HVLT Delayed Recall Total |
6.8; 7.8 | — |
| PRIMARY Cognitive Function- Trails A |
60.6; 52.3 | — |
| PRIMARY Cognitive Function- Trails B |
131.5; 118.6 | — |
| PRIMARY Cognitive Function- CPT D Prime Score |
1.9; 2.1 | — |
| PRIMARY Cognitive Function- CPT Hits Rate (Proportion) |
0.7; 0.7 | — |
| PRIMARY Cognitive Function- CPT Reaction Time of Hits (Milliseconds) |
554.1; 552.9 | — |
| PRIMARY Cognitive Function- CPT False-alarm Rate (Proportion) |
0.1; 0.1 | — |
| PRIMARY Psychopathology- PANSS Total |
74.3; 74.1 | — |
| PRIMARY Psychopathology- PANSS Positive |
17.2; 16.8 | — |
| PRIMARY Psychopathology- PANSS Negative |
20.8; 20.7 | — |
| PRIMARY Psychopathology- PANSS General Psychopathology |
36.3; 36.6 | — |
| PRIMARY Psychopathology- SANS Total |
30.8; 33.5 | — |
| PRIMARY Psychopathology- CDSS Total |
2.1; 2.7 | — |
| PRIMARY Psychopathology- QLS Total |
70.9; 67 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00575666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.