Official Title: “Family Therapy in the Treatment of Adolescent Anorexia Nervosa”

This study will compare the effectiveness of two different family treatments for the treatment of adolescent anorexia nervosa.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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. 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 the two types of family therapy. Family therapy will be given for 36-weeks. 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 40-hours. In a sub-study blood will be drawn from those volunteering for genetic analysis focusing on the subset of non-responders to treatments.

Intervention(s) in this Clinical Trial

• Behavioral: Family therapy

Primary Measures

• Body Mass Index

Secondary Measures

• Eating Disorder Psychopathology

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stanford University

Overall Clinical Trial Officials and Contacts

Blake Woodside Principal Investigator Toronto General Hospital  

Overall Contact: William S Agras, MD (650) 725-5734 sagras@stanford.edu

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00610753

Study ID Number: SU-12132007-933

ClinicalTrials.gov Identifier: NCT00610753

Health Authority: US:U.S: Institutional Review Board

Study description and password protected study documents