Obesity, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
obesity, schizophrenia, schizoaffective disorder, weight loss
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.
Interventions
DRUGNaltrexone 25mg
Naltrexone 25mg caplets taken orally once a day for 8 weeks
OTHERPlacebo
Placebo caplet (inactive substance) taken orally once a day for 8 weeks
Sponsors
Ethel F. Donaghue Women's Health Investigator Program at Yale
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight From Baseline | 8 weeks | Weight was measured with shoes off to the nearest 0.1 kg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Serum Glucose Lab Values | baseline and 8 weeks | — |
| PANSS- Positive and Negative Symptom Scale | 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 | baseline and week 8 | Determined with a double-antibody radioimmunoassay |
| LDL Cholesterol | baseline and week 8 | Determined by standard enzymatic procedures |
| Change in Questionnaire on Craving for Sweet or Rich Foods Score | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naltrexone 25mg Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks | 11 |
| Placebo Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks | 12 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Naltrexone 25mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 9.6 | 41.4 years STANDARD_DEVIATION 11.6 | 46.93 years STANDARD_DEVIATION 10.73 |
| Diabetes Diabetic | 6 participants | 1 participants | 7 participants |
| Diabetes Non-Diabetic | 5 participants | 11 participants | 16 participants |
| Diagnosis Schizoaffective | 4 participants | 7 participants | 11 participants |
| Diagnosis Schizophrenia | 7 participants | 5 participants | 12 participants |
| PANSS Total Score | 64.7 units on a scale STANDARD_DEVIATION 17.2 | 56.0 units on a scale STANDARD_DEVIATION 16.7 | 59.78 units on a scale STANDARD_DEVIATION 16.42 |
| Race/Ethnicity, Customized Black | 7 participants | 4 participants | 11 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 4 participants | 7 participants | 11 participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Years of education | 13.4 years STANDARD_DEVIATION 4.1 | 13.7 years STANDARD_DEVIATION 3.9 | 13.52 years STANDARD_DEVIATION 3.89 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 10 | 5 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
Primary
Change in Body Weight From Baseline
Weight was measured with shoes off to the nearest 0.1 kg.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Naltrexone 25mg | Change in Body Weight From Baseline | -3.40 kg |
| Placebo | Change in Body Weight From Baseline | 1.37 kg |
Secondary
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.
Time frame: baseline and week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naltrexone 25mg | Change in Questionnaire on Craving for Sweet or Rich Foods Score | -3.10 units on a scale | Standard Deviation 3.92 |
| Placebo | Change in Questionnaire on Craving for Sweet or Rich Foods Score | 0 units on a scale | Standard Deviation 4.31 |
Secondary
Fasting Serum Glucose Lab Values
Time frame: baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naltrexone 25mg | Fasting Serum Glucose Lab Values | baseline | 113.40 mg/dL | Standard Deviation 28.2 |
| Naltrexone 25mg | Fasting Serum Glucose Lab Values | Week 8 | 129.22 mg/dL | Standard Deviation 45.2 |
| Placebo | Fasting Serum Glucose Lab Values | baseline | 93.82 mg/dL | Standard Deviation 7.9 |
| Placebo | Fasting Serum Glucose Lab Values | Week 8 | 94.11 mg/dL | Standard Deviation 7.5 |
Secondary
Insulin Levels
Determined with a double-antibody radioimmunoassay
Time frame: baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naltrexone 25mg | Insulin Levels | baseline | 26.42 microIU/mL | Standard Deviation 40 |
| Naltrexone 25mg | Insulin Levels | Week 8 | 35.51 microIU/mL | Standard Deviation 42 |
| Placebo | Insulin Levels | baseline | 13.84 microIU/mL | Standard Deviation 10.8 |
| Placebo | Insulin Levels | Week 8 | 12.36 microIU/mL | Standard Deviation 4.4 |
Secondary
LDL Cholesterol
Determined by standard enzymatic procedures
Time frame: baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naltrexone 25mg | LDL Cholesterol | baseline | 86.80 mg/dL | Standard Deviation 26.2 |
| Naltrexone 25mg | LDL Cholesterol | Week 8 | 104.11 mg/dL | Standard Deviation 39.9 |
| Placebo | LDL Cholesterol | baseline | 123.18 mg/dL | Standard Deviation 41.3 |
| Placebo | LDL Cholesterol | Week 8 | 111.22 mg/dL | Standard Deviation 33.5 |
Secondary
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naltrexone 25mg | PANSS- Positive and Negative Symptom Scale | 57.50 units on a scale | Standard Deviation 16.17 |
| Placebo | PANSS- Positive and Negative Symptom Scale | 52.63 units on a scale | Standard Deviation 17.91 |