Comparison of Two Types of Family Therapy in the Treatment of Adolescent Anorexia Nervosa
Information source: Stanford University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anorexia Nervosa
Intervention: Family therapy (Behavioral)
Phase: Phase 3
Status: Recruiting
Sponsored by: Stanford University Official(s) and/or principal investigator(s):
Blake Woodside, Principal Investigator, Affiliation: Toronto General Hospital
Craig Johnson, Principal Investigator, Affiliation: Laureate Psychiatric Clinic & Hospital
Denise Wilfley, Principal Investigator, Affiliation: Washington University, Department of Psychiatry
Harry ABrandt, Principal Investigator, Affiliation: Sheppard Pratt Health System
James D Lock, Sub-Investigator, Affiliation: Stanford University
Katherine Halmi, Principal Investigator, Affiliation: Department of Psychiatry, Cornell University
Walter HKaye, Principal Investigator, Affiliation: UCSD Center for Eating Disorder Treatment & Research
William SAgras, Study Chair, Affiliation: Stanford University
Overall contact:
William S Agras, MD, Phone: (650) 725-5734, Email: sagras@stanford.edu
Summary
This study will compare the effectiveness of two different family treatments and
fluoxetine/placebo for the treatment of adolescent anorexia nervosa.
Clinical Details
Official title: Family Therapy in the Treatment of Adolescent Anorexia Nervosa
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: Body Mass Index
Secondary outcome: Eating Disorder Psychopathology
Detailed description:
The long-term objective of this study is to enhance the treatment and outcome of anorexia
nervosa (AN). Research on the treatment of AN has lagged that of other conditions, even other
eating disorders such as bulimia nervosa. The focus of this study is on adolescent AN.
Successful early treatment is likely to reduce the prevalence of chronic AN with its high
rates of morbidity and mortality and high health care costs. The most promising treatment for
adolescent AN is a specific form of family therapy called behavioral family therapy (BFT).
This treatment is focused on the disordered eating behavior that characterizes AN and enables
parents to refeed their child. Additionally, there is preliminary evidence that fluoxetine
may be useful in reducing comorbid psyhopathology. However, there has been no
placebo-controlled trial of fluoxetine in adolescent AN, and although there have been several
small scale studies of BFT there has been no controlled comparison with another form of
family therapy. Therefore we propose to use systems family therapy (SFT) which has been
developed to represent the type of family therapy practiced in the community.
Two hundred and forty adolescents of both genders aged 12-18 years meeting DSM-IV criteria
for anorexia nervosa will be entered to the study. Recruitment is projected to extend for 2
years. Participants will randomly allocated to one of four groups: SFT + fluoxetine; BFT +
fluoxetine; SFT + placebo; BFT + placebo. Family therapy and medication will be given for
48-weeks and then medication will continue for a further 6-months to assess the effects of
medication in maintaining gains achieved in treatment. For the purpose of the present study,
patients will be followed for 12-months after the end of family treatment. Hence, each
family will participate for approximately 2-years, with a total participation time of some
50-hours. In a sub-study blood will be drawn from those volunteering for genetic analysis
focusing on the subset of non-responders to treatments.
Eligibility
Minimum age: 12 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria: Diagnosis of anorexia nervosa with Ideal Body Weight >75%
Exclusion
Criteria: Current psychotic illness or mental retardation that would prohibit the use of
psychotherapy Medically unstable for outpatient treatment
Locations and Contacts
William S Agras, MD, Phone: (650) 725-5734, Email: sagras@stanford.edu
Stanford University, Stanford, California 94305, United States; Not yet recruiting
William S Agras, MD, Phone: 650725573, Email: sagras@stanford.edu
William S Agras, Study Chair
UCSD Center for Eating Disorder Treatment & Research, San Diego, California 92037, United States; Recruiting
Roxanne Rockwell, BS, Phone: 858-366-2525, Email: edresearch@ucsd.edu
Walter H Kaye, Principal Investigator
Stanford University School of Medicine, Stanford, California 94305, United States; Not yet recruiting
William S Agras, MD, Phone: 650-725-5734, Email: sagras@stanford.edu
James D Lock, Sub-Investigator
Sheppard-Pratt Health System, Baltimore, Maryland 21204, United States; Recruiting
Harry A Brandt, MD, Phone: 410-427-3888, Email: hbrandt@sheppardpratt.org
Harry A Brandt, Principal Investigator
Washington University, Department of Psychiatry, St Louis, Missouri 63110, United States; Recruiting
Denise Wilfley, Ph.D, Phone: 314-286-2079, Email: wilfleyd@psychiatry.wustl.edu
Denise Wilfley, Principal Investigator
Department of Psychiatry, Cornell University, White Plains, New York 10605, United States; Recruiting
Katherine Halmi, MD, Phone: 914-997-5875, Email: kah29@cornell.edu
Katherine Halmi, Principal Investigator
Laureate Psychiatric Clinic & Hospital, Tulsa, Oklahoma 74136, United States; Recruiting
Craig Johnson, Ph.D, Phone: 918491370, Email: CJohnsonPhD@Laureate.com
Craig Johnson, Principal Investigator
Toronto General Hospital, Toronto, Ontario M5G 2, Canada; Recruiting
Blake Woodside, MD, Phone: (416) 340-4445, Email: b.woodside@utoronto.ca
Blake Woodside, Principal Investigator
Additional Information
Study description and password protected study documents
Starting date: July 2006
Ending date: April 2011
Last updated: October 24, 2008
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