Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
|ClinicalTrials.gov Identifier: NCT00793780|
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : October 6, 2016
Last Update Posted : October 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity Schizophrenia Schizoaffective Disorder||Drug: Naltrexone 25mg Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
|Active Comparator: Naltrexone 25mg||
Drug: Naltrexone 25mg
Naltrexone 25mg caplets taken orally once a day for 8 weeks
|Placebo Comparator: Placebo||
Placebo caplet (inactive substance) taken orally once a day for 8 weeks
- Change in Body Weight From Baseline [ Time Frame: 8 weeks ]Weight was measured with shoes off to the nearest 0.1 kg.
- Fasting Serum Glucose Lab Values [ Time Frame: baseline and 8 weeks ]
- PANSS- Positive and Negative Symptom Scale [ Time Frame: 8 weeks ]The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.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.
- Insulin Levels [ Time Frame: baseline and week 8 ]Determined with a double-antibody radioimmunoassay
- LDL Cholesterol [ Time Frame: baseline and week 8 ]Determined by standard enzymatic procedures
- Change in Questionnaire on Craving for Sweet or Rich Foods Score [ Time Frame: baseline and week 8 ]The Questionnaire on Craving for Sweet or Rich Foods (QCSRF) is a 2-factor, 9-item scale assessing the presence of cravings for rich and sweet foods and has been found to have good psychometric properties. The total score is the total of 2 sub scales. Total range is from 9 to 63, with a higher score indicative of a higher craving and reinforcement from sweet and/or rich foods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793780
|United States, Connecticut|
|Connecticut Mental Health Center|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Cenk Tek, M.D.||Yale University|