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A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00140426
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Collaborators:
Janssen Pharmaceuticals
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 1, 2005
Results First Submitted Date  ICMJE June 8, 2015
Results First Posted Date  ICMJE February 2, 2016
Last Update Posted Date February 2, 2016
Study Start Date  ICMJE August 2004
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
  • Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT) [ Time Frame: month ]
    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.
  • Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD) [ Time Frame: monthly ]
    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.
  • Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior) [ Time Frame: weekly up to study endpoint: reaching target weight and maintaining for 1 month ]
    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.
  • Color A Person Test (CAPT) [ Time Frame: monthly ]
    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.
  • Body Image Software (BIS): Average Distortion [ Time Frame: monthly ]
    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"
  • Body Image Software (BIS): Average Desired Thinness [ Time Frame: monthly ]
    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.
  • Body Image Software (BIS) - Point of Subjective Equality (PSE) [ Time Frame: monthly ]
    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.
  • Body Image Software (BIS) - Difference Limen (DL) [ Time Frame: monthly ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
  • 1. Change in body image distortion and body satisfaction
  • 2. Change in Eating Disorder Inventory-2 Score
  • 3. Number of days from start of study to reach ease of eating level 3 (Normal eating behavior)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
  • Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study [ Time Frame: weekly ]
    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.
  • Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: monthly to study end point ]
    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.
  • Change in Leptin Levels [ Time Frame: Week 0 and week 7 ]
    Leptin levels were measured by serum blood draws, results reports in nanograms / ml (ng/ml).
  • Change in Prolactin Levels [ Time Frame: week 0 and week 7 ]
    Prolactin serum blood levels, measured in nanograms / ml
  • Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study [ Time Frame: 0 - 18 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
  • 1. Time to reach 90% IBW and maintain for 1 month, stratified by %IBW at start of study
  • 2. Change in ratings of anxiety symptoms on the MASC
  • 3. Change in leptin levels
  • 4. Safety and tolerability of risperidone as measured by liver enzymes, prolactin levels, triglycerides, glucose, cholesterol, ECG, REE and side effect rating scales - Simpson and AIMS.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Official Title  ICMJE A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Brief Summary

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.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anorexia Nervosa
Intervention  ICMJE
  • Drug: Risperidone
    risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.
    Other Name: Risperdal
  • Drug: Placebo
    Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.
    Other Name: placebo - inactive pill
Study Arms  ICMJE
  • Placebo Comparator: placebo
    double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
    Intervention: Drug: Placebo
  • Active Comparator: risperidone
    Study is double blind, placebo controlled. This is the subject group on active medication
    Intervention: Drug: Risperidone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2011)
41
Original Enrollment  ICMJE
 (submitted: August 31, 2005)
50
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Primary Diagnosis of Anorexia Nervosa
  • Female, age 12-21
  • Active in a level of care for AN at The Children's Hospital, Denver
  • As long as there is a primary dx of AN, co-morbid diagnoses may be included.
  • If taking an antidepressant, must be on a stable dose for 3 weeks prior to entering the study, and dose of antidepressant may not be changed during Phase 1 of the study.
  • If choosing to discontinue antidepressant medication, must be off the medication for 3 weeks prior to beginning the study.
  • If sexually active, must use birth control during the study and have a monthly pregnancy test.

Exclusion Criteria:

  • Previous enrollment in this study on a prior admission
  • Previous allergic reaction to risperidone or other atypical neuroleptic
  • Positive pregnancy test
  • Neurologic disorder other than benign essential tremor
  • Taking a psychotropic medication other than antidepressant and discontinuing the medication is not recommended.
  • Active hepatic or renal disease
  • Wards of the state
  • Males
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00140426
Other Study ID Numbers  ICMJE 03-0673
5M01RR000069-45 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Colorado, Denver
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Colorado, Denver
Original Study Sponsor  ICMJE Children's Hospital Colorado
Collaborators  ICMJE
  • Janssen Pharmaceuticals
  • National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Jennifer O Hagman, MD University of Colorado, Health Sciences Center and The Children's Hospital, Denver
PRS Account University of Colorado, Denver
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP