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Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Ethel F. Donaghue Women's Health Investigator Program at Yale
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00793780
First received: November 18, 2008
Last updated: August 12, 2016
Last verified: August 2016
Results First Received: June 28, 2016  
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
Conditions: Obesity
Schizophrenia
Schizoaffective Disorder
Interventions: Drug: Naltrexone 25mg
Other: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Naltrexone 25mg Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
Placebo Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks

Participant Flow:   Overall Study
    Naltrexone 25mg   Placebo
STARTED   12   12 
Randomization   12   12 
Collected Baseline Data   11   12 
COMPLETED   10   11 
NOT COMPLETED   2   1 
Withdrawal by Subject                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Overweight women between the ages of 18 and 70 years who met the DSM-IV criteria for schizophrenia or schizoaffective disorder, on the basis of Structured Clinical Interview for DSM-IV. An additional participant dropped out of the study after baseline data was collected.

Reporting Groups
  Description
Naltrexone 25mg Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
Placebo Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
Total Total of all reporting groups

Baseline Measures
    Naltrexone 25mg   Placebo   Total
Overall Participants Analyzed 
[Units: Participants]
 11   12   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (9.6)   41.4  (11.6)   46.93  (10.73) 
Gender 
[Units: Participants]
     
Female   11   12   23 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   4   7   11 
Black   7   4   11 
Hispanic   0   1   1 
Diagnosis 
[Units: Participants]
     
Schizophrenia   7   5   12 
Schizoaffective   4   7   11 
PANSS Total Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 64.7  (17.2)   56.0  (16.7)   59.78  (16.42) 
[1] The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The scores for these scales are arrived at by summation of ratings across component items. Total score ranges from a minimum of 30 to a maximum of 210. A higher score indicates more severe symptoms.
Diabetes 
[Units: Participants]
     
Diabetic   6   1   7 
Non-Diabetic   5   11   16 
Years of education 
[Units: Years]
Mean (Standard Deviation)
 13.4  (4.1)   13.7  (3.9)   13.52  (3.89) 


  Outcome Measures
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1.  Primary:   Change in Body Weight From Baseline   [ Time Frame: 8 weeks ]

2.  Secondary:   Fasting Serum Glucose Lab Values   [ Time Frame: baseline and 8 weeks ]

3.  Secondary:   PANSS- Positive and Negative Symptom Scale   [ Time Frame: 8 weeks ]

4.  Secondary:   Insulin Levels   [ Time Frame: baseline and week 8 ]

5.  Secondary:   LDL Cholesterol   [ Time Frame: baseline and week 8 ]

6.  Secondary:   Change in Questionnaire on Craving for Sweet or Rich Foods Score   [ Time Frame: baseline and week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Erin Sullivan
Organization: Yale University
phone: +1 (203) 974-7317
e-mail: erin.reutenauer@yale.edu


Publications of Results:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00793780     History of Changes
Other Study ID Numbers: 0808004106
Study First Received: November 18, 2008
Results First Received: June 28, 2016
Last Updated: August 12, 2016
Health Authority: United States: Institutional Review Board