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| Name | Class |
|---|---|
| Ethel F. Donaghue Women's Health Investigator Program at Yale | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone 25mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone 25mg | Drug | Naltrexone 25mg caplets taken orally once a day for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight From Baseline | Weight was measured with shoes off to the nearest 0.1 kg. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Serum Glucose Lab Values | baseline and 8 weeks | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cenk Tek, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25102328 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone 25mg | Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks |
| FG001 | Placebo | Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone 25mg | Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks |
| BG001 | Placebo | Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight From Baseline | Weight was measured with shoes off to the nearest 0.1 kg. | Posted | Mean | 95% Confidence Interval | kg | 8 weeks |
|
|
Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naltrexone 25mg | Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concentration | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Sullivan | Yale University | +1 (203) 974-7317 | erin.reutenauer@yale.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Placebo |
| Other |
Placebo caplet (inactive substance) taken orally once a day for 8 weeks |
|
| 8 weeks |
| Insulin Levels | Determined with a double-antibody radioimmunoassay | baseline and week 8 |
| LDL Cholesterol | Determined by standard enzymatic procedures | baseline and week 8 |
| 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. | baseline and week 8 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Diagnosis | Number | participants |
|
| PANSS Total Score | 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. | Mean | Standard Deviation | units on a scale |
|
| Diabetes | Number | participants |
|
| Years of education | Mean | Standard Deviation | years |
|
| Participants |
|
|
| Secondary | Fasting Serum Glucose Lab Values | Posted | Mean | Standard Deviation | mg/dL | baseline and 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Insulin Levels | Determined with a double-antibody radioimmunoassay | Posted | Mean | Standard Deviation | microIU/mL | baseline and week 8 |
|
|
|
| Secondary | LDL Cholesterol | Determined by standard enzymatic procedures | Posted | Mean | Standard Deviation | mg/dL | baseline and week 8 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and week 8 |
|
|
|
| 0 |
| 10 |
| 9 |
| 10 |
| EG001 | Placebo | Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks | 0 | 11 | 5 | 11 |
| Fatigue | General disorders | Systematic Assessment |
|
| Sedation | General disorders | Non-systematic Assessment |
|
| Failing Memory | Psychiatric disorders | Systematic Assessment |
|
| Tension | General disorders | Systematic Assessment |
|
| Increased Sleep | General disorders | Systematic Assessment |
|
| Decreased Sleep | General disorders | Systematic Assessment |
|
| Increased Dreaming | General disorders | Systematic Assessment |
|
| Emotional Indifference | Psychiatric disorders | Systematic Assessment |
|
| Dystonia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rigidity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tremor | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Increased Saliva | General disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Photosensitivity | General disorders | Systematic Assessment |
|
| Weight Loss | General disorders | Systematic Assessment |
|
| Decreased Sexual Desire | General disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |