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Intranasal Insulin Treatment in Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Eli Lilly and Company
Information provided by (Responsible Party):
Xiaoduo Fan, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00575666
First received: December 14, 2007
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
Results First Received: April 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Insulin or Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the Freedom Trail Clinic at the Erich Lindemann Mental Health Center and were studied at the Massachusetts General Hospital Clinical Research Center (MGH CRC), Boston.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After providing written informed consent, subjects underwent a diagnostic evaluation by a research psychiatrist using the Structured Clinical Interview for DSM-IV (SCID). All subjects were screened and enrolled based on eligibility criteria. Baseline study assessments were completed prior to intervention.

Reporting Groups
  Description
Intervention: Insulin Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
Intervention: Placebo Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up

Participant Flow:   Overall Study
    Intervention: Insulin     Intervention: Placebo  
STARTED     21     24  
COMPLETED     17     21  
NOT COMPLETED     4     3  
Withdrawal by Subject                 3                 2  
Physician Decision                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Intervention: Insulin Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
Intervention: Placebo Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
Total Total of all reporting groups

Baseline Measures
    Intervention: Insulin     Intervention: Placebo     Total  
Number of Participants  
[units: participants]
 		  21     24     45  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     21     24     45  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  49.2  ± 9.3     43.8  ± 9.2     46.0  ± 9.0  
Gender  
[units: participants]
 		     
Female     3     6     9  
Male     18     18     36  
Region of Enrollment  
[units: participants]
 		     
United States     21     24     45  



  Outcome Measures
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1.  Primary:   Cognitive Function- Digit Span Total   [ Time Frame: Week 8 ]
  Show Outcome Measure 1

2.  Primary:   Cognitive Function- Verbal Fluency   [ Time Frame: Week 8 ]
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3.  Primary:   Cognitive Function- HVLT Immediate Recall Total   [ Time Frame: Week 8 ]
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4.  Primary:   Cognitive Function- HVLT Delayed Recall Total   [ Time Frame: Week 8 ]
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5.  Primary:   Cognitive Function- Trails A   [ Time Frame: Week 8 ]
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6.  Primary:   Cognitive Function- Trails B   [ Time Frame: Week 8 ]
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7.  Primary:   Cognitive Function- CPT D Prime Score   [ Time Frame: Week 8 ]
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8.  Primary:   Cognitive Function- CPT Hits Rate (Proportion)   [ Time Frame: Week 8 ]
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9.  Primary:   Cognitive Function- CPT Reaction Time of Hits (Milliseconds)   [ Time Frame: Week 8 ]
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10.  Primary:   Cognitive Function- CPT False-alarm Rate (Proportion)   [ Time Frame: Week 8 ]
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11.  Primary:   Psychopathology- PANSS Total   [ Time Frame: Week 8 ]
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12.  Primary:   Psychopathology- PANSS Positive   [ Time Frame: Week 8 ]
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13.  Primary:   Psychopathology- PANSS Negative   [ Time Frame: Week 8 ]
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14.  Primary:   Psychopathology- PANSS General Psychopathology   [ Time Frame: Week 8 ]
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15.  Primary:   Psychopathology- SANS Total   [ Time Frame: Week 8 ]
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16.  Primary:   Psychopathology- CDSS Total   [ Time Frame: Week 8 ]
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17.  Primary:   Psychopathology- QLS Total   [ Time Frame: Week 8 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Xiaoduo Fan, MD, MPH, MS
Organization: UMass Medical School
phone: 508-856-3881
e-mail: Xiaoduo.Fan@umassmed.edu


No publications provided


Responsible Party: Xiaoduo Fan, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00575666     History of Changes
Other Study ID Numbers: 2007-P-000731
Study First Received: December 14, 2007
Results First Received: April 27, 2012
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board