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| ID | Type | Description | Link |
|---|---|---|---|
| 5M01RR000069-45 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Janssen Pharmaceuticals | INDUSTRY |
| National Center for Research Resources (NCRR) | NIH |
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The aim of this pilot study is to determine the safety and efficacy of risperidone for the treatment of anorexia nervosa.
Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image distortion and Eating Disorder Inventory -2 scores than subjects on placebo.
Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body weight sooner than controls.
The lack of effective medications for the symptoms of anorexia nervosa (AN), combined with early promising findings in case reports (Risperidone and Olanzapine) and one open study of olanzapine have led to increased use of these medications for individuals with AN. This double-blind placebo controlled study of risperidone will attempt to determine if risperidone is effective in decreasing core symptoms of anorexia nervosa and decreasing the length of time required to reach and maintain at or about 90% Ideal body weight. The safety of risperidone in this population will also be examined through monitoring of Extrapyramidal Symptoms, Tardive Dyskinesia, Electrocardiograms's, Resting Energy Expenditure, liver enzymes and other blood chemistry. Other possible variables which may mediate the recovery process or be impacted by risperidone,such as leptin and anxiety symptoms are also being measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo. |
|
| risperidone | Active Comparator | Study is double blind, placebo controlled. This is the subject group on active medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT) | Eating Disorder Inventory -2 - Subscale : Drive for Thinness Subscale (DT). Lower scores are better on this scale and indicate less cognitive focus on drive for thinness. The EDI 2 is a 91 item scale with 8 subscales - (Drive for thinness, Bulimia, body dissatisfaction, ineffectiveness, perfection, interpersonal distrust, interoceptive awareness and maturity fears.). The DT subscale was used for this outcome. Respondents rate each item as "usually , often, sometimes, rarely or never". Subscale scores are computed by summing all item scores for each subscale. There are 7 items in the DT subscale (questions 1,7,11,16,25,32 and 49). the subscale score range is 0-21. The EDI-2 was completed by subjects at baseline and then monthly during study participation (range 0 -18 weeks). Change in the DT subscale score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. | month |
| Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD) | change in Eating Disorder Inventory (EDI) 2-score for Body Dissatisfaction (BD). Lower scores are better on this scale. Higher scores indicate the subject has greater body dissatisfaction. BD is one of the 8 subscales of the EDI-2. 9 of the 91 questions in the EDI-2 scale constitute this subscale. The score range is 0-27. Subjects completed the EDI-2 at baseline and monthly during study participation (range 0 to 18 weeks). Change in the BD subscale score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. | monthly |
| Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior) | The Ease of Eating Scale (EOES) is a 14 item scale which measures Food avoidance behaviors (FABs). The scale is rated by staff observing a subject eating a meal or snack. 0 = normal eating behavior, maximum score 28. Higher scores indicate more food avoidance behaviors, such as taking small bites, taking > 30 seconds between bites (slow eating), etc. EOE was completed for each meal a subject ate in the program and scores were averaged for each week in the study and entered in the data base. Change in EOES score was calculated by evaluating change over time. This measure was only used in Phase 1 of the study, for days the subjects were in the treatment program. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study | The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities. This was measured weekly from 0-18 weeks. | weekly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer O Hagman, MD | University of Colorado, Health Sciences Center and The Children's Hospital, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital | Denver | Colorado | 80218 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21871373 | Derived | Hagman J, Gralla J, Sigel E, Ellert S, Dodge M, Gardner R, O'Lonergan T, Frank G, Wamboldt MZ. A double-blind, placebo-controlled study of risperidone for the treatment of adolescents and young adults with anorexia nervosa: a pilot study. J Am Acad Child Adolesc Psychiatry. 2011 Sep;50(9):915-24. doi: 10.1016/j.jaac.2011.06.009. Epub 2011 Aug 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo. Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks. |
| FG001 | Risperidone | Study is double blind, placebo controlled. This is the subject group on active medication Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Females age 12 - 21
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo. Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks. |
| BG001 | Risperidone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Eating Disorder Inventory-2 Drive for Thinness Subscale (DT) | Eating Disorder Inventory -2 - Subscale : Drive for Thinness Subscale (DT). Lower scores are better on this scale and indicate less cognitive focus on drive for thinness. The EDI 2 is a 91 item scale with 8 subscales - (Drive for thinness, Bulimia, body dissatisfaction, ineffectiveness, perfection, interpersonal distrust, interoceptive awareness and maturity fears.). The DT subscale was used for this outcome. Respondents rate each item as "usually , often, sometimes, rarely or never". Subscale scores are computed by summing all item scores for each subscale. There are 7 items in the DT subscale (questions 1,7,11,16,25,32 and 49). the subscale score range is 0-21. The EDI-2 was completed by subjects at baseline and then monthly during study participation (range 0 -18 weeks). Change in the DT subscale score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. | Posted | Mean | Standard Deviation | units on a scale | month |
|
While patients were on the study medication (placebo or risperidone)
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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 | Placebo | double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo. Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Hagman MD | University of Colorado School of Medicine, Childrens Hospital Colorado | 720-777-2539 | jennifer.hagman@childrenscolorado.org |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. |
|
|
| weekly up to study endpoint: reaching target weight and maintaining for 1 month |
| Color A Person Test (CAPT) | Color A Person Test (CAPT) - Subjects color an outlined image of a body to indicate body dissatisfaction (red (5)= very dissatisfied, Yellow, dissatisfied, black, neutral, green satisfied, blue very satisfied (1). The outline is divided into16 sections for scoring. The CAPT was completed at baseline and monthly during study participation. Total CAPT scores were calculated by adding the total score and dividing by 16. Score range is 1-5. Lower scores indicate less body dissatisfaction. Change in the CAPT score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. | monthly |
| Body Image Software (BIS): Average Distortion | Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer using the direction to "adjust their image to how they see themselves right now", this determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image. Change in the BIS Average Distortion score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. The BIS program calculates the difference between their actual image and the size of the image they have adjusted the digital image to based on their perception of "how they see themselves right now" | monthly |
| Body Image Software (BIS): Average Desired Thinness | Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to "their desired image". The BIS program calculates the difference between their actual image, and how much they have adjusted the image to represent their "desired image". Accuracy is measured by a smaller score between desired image and actual image. Change in BIS - Average Desired Thinness score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. There are no identifiable minimum/maximum values as there would be in a questionnaire scale. . There are no subscales. | monthly |
| Body Image Software (BIS) - Point of Subjective Equality (PSE) | Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image. Change in BIS -PSE was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. There are no identifiable minimum/maximum values as there would be in a questionnaire scale. Interpreting the PSE is how it compares to a PSE = 0, which is no distortion in body size. | monthly |
| Body Image Software (BIS) - Difference Limen (DL) | Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image. Change in BIS-DL was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. Interpreting the DL occurs by referencing it to DL= 0, which would reflect a total inability to detect size differences, which has never occurred in studies using the BIS program. | monthly |
| Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC) | The Multidimensional Anxiety Scale for Children (MASC) is a self report measure completed by the subject that measures anxiety symptoms. Higher scores indicate greater anxiety. A score of over 50 is significant for anxiety Change in MASC scores was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. | monthly to study end point |
| Change in Leptin Levels | Leptin levels were measured by serum blood draws, results reports in nanograms / ml (ng/ml). | Week 0 and week 7 |
| Change in Prolactin Levels | Prolactin serum blood levels, measured in nanograms / ml | week 0 and week 7 |
| Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study | The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities. | 0 - 18 weeks |
Study is double blind, placebo controlled. This is the subject group on active medication Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo. Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks. |
| OG001 | Risperidone | Study is double blind, placebo controlled. This is the subject group on active medication Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW. |
|
|
| Primary | Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD) | change in Eating Disorder Inventory (EDI) 2-score for Body Dissatisfaction (BD). Lower scores are better on this scale. Higher scores indicate the subject has greater body dissatisfaction. BD is one of the 8 subscales of the EDI-2. 9 of the 91 questions in the EDI-2 scale constitute this subscale. The score range is 0-27. Subjects completed the EDI-2 at baseline and monthly during study participation (range 0 to 18 weeks). Change in the BD subscale score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. | 1 risperidone subject was missing data for BD at this data point. | Posted | Mean | Standard Deviation | units on a scale | monthly |
|
|
|
| Primary | Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior) | The Ease of Eating Scale (EOES) is a 14 item scale which measures Food avoidance behaviors (FABs). The scale is rated by staff observing a subject eating a meal or snack. 0 = normal eating behavior, maximum score 28. Higher scores indicate more food avoidance behaviors, such as taking small bites, taking > 30 seconds between bites (slow eating), etc. EOE was completed for each meal a subject ate in the program and scores were averaged for each week in the study and entered in the data base. Change in EOES score was calculated by evaluating change over time. This measure was only used in Phase 1 of the study, for days the subjects were in the treatment program. | 2 patients in the placebo group were treated as inpatients and had no EOE data. | Posted | Number | 95% Confidence Interval | hazard ratio | weekly up to study endpoint: reaching target weight and maintaining for 1 month |
|
|
|
|
| Secondary | Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study | The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities. This was measured weekly from 0-18 weeks. | Posted | Mean | Standard Error | weeks | weekly |
|
|
|
| Secondary | Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC) | The Multidimensional Anxiety Scale for Children (MASC) is a self report measure completed by the subject that measures anxiety symptoms. Higher scores indicate greater anxiety. A score of over 50 is significant for anxiety Change in MASC scores was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. | Posted | Mean | Standard Deviation | units on a scale | monthly to study end point |
|
|
|
| Secondary | Change in Leptin Levels | Leptin levels were measured by serum blood draws, results reports in nanograms / ml (ng/ml). | Posted | Mean | Standard Deviation | ng/ml | Week 0 and week 7 |
|
|
|
| Secondary | Change in Prolactin Levels | Prolactin serum blood levels, measured in nanograms / ml | Posted | Mean | Standard Deviation | ng/ml | week 0 and week 7 |
|
|
|
|
| Secondary | Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study | The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities. | Posted | Mean | Standard Error | weeks | 0 - 18 weeks |
|
|
|
| Primary | Color A Person Test (CAPT) | Color A Person Test (CAPT) - Subjects color an outlined image of a body to indicate body dissatisfaction (red (5)= very dissatisfied, Yellow, dissatisfied, black, neutral, green satisfied, blue very satisfied (1). The outline is divided into16 sections for scoring. The CAPT was completed at baseline and monthly during study participation. Total CAPT scores were calculated by adding the total score and dividing by 16. Score range is 1-5. Lower scores indicate less body dissatisfaction. Change in the CAPT score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. | Posted | Mean | Standard Deviation | units on a scale | monthly |
|
|
|
|
| Primary | Body Image Software (BIS): Average Distortion | Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer using the direction to "adjust their image to how they see themselves right now", this determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image. Change in the BIS Average Distortion score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. The BIS program calculates the difference between their actual image and the size of the image they have adjusted the digital image to based on their perception of "how they see themselves right now" | Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement. | Posted | Mean | Standard Deviation | units on a scale | monthly |
|
|
|
|
| Primary | Body Image Software (BIS): Average Desired Thinness | Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to "their desired image". The BIS program calculates the difference between their actual image, and how much they have adjusted the image to represent their "desired image". Accuracy is measured by a smaller score between desired image and actual image. Change in BIS - Average Desired Thinness score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. There are no identifiable minimum/maximum values as there would be in a questionnaire scale. . There are no subscales. | Many patients did not complete this outcome measurement. Change from baseline to end of study were compared between arms. | Posted | Mean | Standard Deviation | units on a scale | monthly |
|
|
|
|
| Primary | Body Image Software (BIS) - Point of Subjective Equality (PSE) | Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image. Change in BIS -PSE was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. There are no identifiable minimum/maximum values as there would be in a questionnaire scale. Interpreting the PSE is how it compares to a PSE = 0, which is no distortion in body size. | Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement. | Posted | Mean | Standard Deviation | units on a scale | monthly |
|
|
|
|
| Primary | Body Image Software (BIS) - Difference Limen (DL) | Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image. Change in BIS-DL was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points. There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. Interpreting the DL occurs by referencing it to DL= 0, which would reflect a total inability to detect size differences, which has never occurred in studies using the BIS program. | Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement. | Posted | Mean | Standard Deviation | units on a scale | monthly |
|
|
|
|
| 0 |
| 22 |
| 17 |
| 22 |
| EG001 | Risperidone | Study is double blind, placebo controlled. This is the subject group on active medication Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW. | 0 | 18 | 16 | 18 |
| dizziness | Nervous system disorders | Systematic Assessment |
|
| gastrointestinal complaints | Gastrointestinal disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| insomnia | Nervous system disorders | Systematic Assessment |
|
| Extrapyramidal symptoms (EPS) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Measured on the Simpson rating scale |
|
| Tardive dyskinesia | Nervous system disorders | Systematic Assessment | as measured by the Abnormal Involuntary Movement Scale (AIMS) |
|
Not provided
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| Mean Difference (Final Values) |
| -43.45 |
| Standard Deviation |
| 20.88 |
| 2-Sided |
| No |
| Superiority or Other |