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Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

Primary Purpose

Obesity, Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Naltrexone 25mg
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, schizophrenia, schizoaffective disorder, weight loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women between the ages of 18 to 70
  • Meet DSM-IV (Diagnostic and Statistical Manual version IV) criteria for schizophrenia or schizoaffective disorder based on SCID (Structured Clinical Interview for the DSM-IV) interview
  • Overweight, as defined with a BMI of equal to or greater than 27 kg/m² and continuing weight gain in the past year above 2% of previous years total body weight
  • Be on a stable dose of antipsychotic medication; i.e. at least one month with no dosage change, and two months from an antipsychotic switch; 5) Deemed to be symptomatically stable by the clinical staff in the last two months

Exclusion Criteria:

  • Meet criteria for current alcohol or other substance dependence, opioid use for any reason or positive urine drug screen for opiates
  • A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings
  • Not capable of giving informed consent for participation in this study
  • Ongoing pregnancy
  • Known sensitivity to naltrexone
  • A medical disorder that is known to cause obesity
  • Use of sibutramine, topiramate, amphetamines or over the counter weight remedies
  • Impaired liver functions (greater than 3 times the upper limit of normal)
  • Diagnosed with polycystic ovary syndrome
  • Currently being treated with insulin
  • Current use of Depo-Provera or any natural/synthetic hormone treatment known to cause significant weight gain

Sites / Locations

  • Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Naltrexone 25mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Body Weight From Baseline
Weight was measured with shoes off to the nearest 0.1 kg.

Secondary Outcome Measures

Fasting Serum Glucose Lab Values
PANSS- Positive and Negative Symptom Scale
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
Determined with a double-antibody radioimmunoassay
LDL Cholesterol
Determined by standard enzymatic procedures
Change in Questionnaire on Craving for Sweet or Rich Foods Score
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.

Full Information

First Posted
November 18, 2008
Last Updated
August 12, 2016
Sponsor
Yale University
Collaborators
Ethel F. Donaghue Women's Health Investigator Program at Yale
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1. Study Identification

Unique Protocol Identification Number
NCT00793780
Brief Title
Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
Official Title
Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Ethel F. Donaghue Women's Health Investigator Program at Yale

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical trial is to find out how effective low dose oral naltrexone is on reducing body weight when compared to placebo in women with schizophrenia and schizoaffective disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Schizophrenia, Schizoaffective Disorder
Keywords
obesity, schizophrenia, schizoaffective disorder, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone 25mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naltrexone 25mg
Intervention Description
Naltrexone 25mg caplets taken orally once a day for 8 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo caplet (inactive substance) taken orally once a day for 8 weeks
Primary Outcome Measure Information:
Title
Change in Body Weight From Baseline
Description
Weight was measured with shoes off to the nearest 0.1 kg.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Fasting Serum Glucose Lab Values
Time Frame
baseline and 8 weeks
Title
PANSS- Positive and Negative Symptom Scale
Description
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.
Time Frame
8 weeks
Title
Insulin Levels
Description
Determined with a double-antibody radioimmunoassay
Time Frame
baseline and week 8
Title
LDL Cholesterol
Description
Determined by standard enzymatic procedures
Time Frame
baseline and week 8
Title
Change in Questionnaire on Craving for Sweet or Rich Foods Score
Description
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.
Time Frame
baseline and week 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women between the ages of 18 to 70 Meet DSM-IV (Diagnostic and Statistical Manual version IV) criteria for schizophrenia or schizoaffective disorder based on SCID (Structured Clinical Interview for the DSM-IV) interview Overweight, as defined with a BMI of equal to or greater than 27 kg/m² and continuing weight gain in the past year above 2% of previous years total body weight Be on a stable dose of antipsychotic medication; i.e. at least one month with no dosage change, and two months from an antipsychotic switch; 5) Deemed to be symptomatically stable by the clinical staff in the last two months Exclusion Criteria: Meet criteria for current alcohol or other substance dependence, opioid use for any reason or positive urine drug screen for opiates A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings Not capable of giving informed consent for participation in this study Ongoing pregnancy Known sensitivity to naltrexone A medical disorder that is known to cause obesity Use of sibutramine, topiramate, amphetamines or over the counter weight remedies Impaired liver functions (greater than 3 times the upper limit of normal) Diagnosed with polycystic ovary syndrome Currently being treated with insulin Current use of Depo-Provera or any natural/synthetic hormone treatment known to cause significant weight gain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cenk Tek, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25102328
Citation
Tek C, Ratliff J, Reutenauer E, Ganguli R, O'Malley SS. A randomized, double-blind, placebo-controlled pilot study of naltrexone to counteract antipsychotic-associated weight gain: proof of concept. J Clin Psychopharmacol. 2014 Oct;34(5):608-12. doi: 10.1097/JCP.0000000000000192.
Results Reference
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Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

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