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| Sponsor: | Stanford University |
|---|---|
| Collaborators: |
Katherine Halmi, MD Craig Johnson, PhD Harry Brandt, MD Walter Kaye MD Blake Woodside MD Denise Wilfley, PhD James D Lock, MD |
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00610753 |
Purpose
This study will compare the effectiveness of two different family treatments for the treatment of adolescent anorexia nervosa.
| Condition | Intervention | Phase |
|---|---|---|
|
Anorexia Nervosa |
Behavioral: Family therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Family Therapy in the Treatment of Adolescent Anorexia Nervosa |
| Estimated Enrollment: | 160 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
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.
One hundred and sixty 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 be 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.
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: James D Lock, MD | (650) 723-5473 | jimlock@stanford.edu |
| United States, California | |
| Stanford University | Not yet recruiting |
| Stanford, California, United States, 94305 | |
| Contact: James D Lock, MD 650-723-5473 jimlock@stanford.edu | |
| Contact: Alaina Critchlow, BA (650) 723-7126 alainac@stanford.edu | |
| Sub-Investigator: James D Lock | |
| UCSD Center for Eating Disorder Treatment & Research | Recruiting |
| San Diego, California, United States, 92037 | |
| Contact: Roxanne Rockwell, BS 858-366-2525 edresearch@ucsd.edu | |
| Principal Investigator: Walter H Kaye | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: William S Agras, MD sagras@stanford.edu | |
| Sub-Investigator: James D Lock | |
| United States, Maryland | |
| Sheppard-Pratt Health System | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| Contact: Harry A Brandt, MD 410-427-3888 hbrandt@sheppardpratt.org | |
| Principal Investigator: Harry A Brandt | |
| United States, Missouri | |
| Washington University, Department of Psychiatry | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| Contact: Denise Wilfley, Ph.D 314-286-2079 wilfleyd@psychiatry.wustl.edu | |
| Principal Investigator: Denise Wilfley | |
| United States, New York | |
| Department of Psychiatry, Cornell University | Recruiting |
| White Plains, New York, United States, 10605 | |
| Contact: Katherine Halmi, MD 914-997-5875 kah29@cornell.edu | |
| Principal Investigator: Katherine Halmi | |
| United States, Oklahoma | |
| Laureate Psychiatric Clinic & Hospital | Active, not recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Canada, Ontario | |
| Toronto General Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2 | |
| Contact: Blake Woodside, MD (416) 340-4445 b.woodside@utoronto.ca | |
| Principal Investigator: Blake Woodside | |
| Principal Investigator: | Blake Woodside | Toronto General Hospital |
| Principal Investigator: | Denise Wilfley | Washington University, Department of Psychiatry |
| Principal Investigator: | Harry ABrandt | Sheppard Pratt Health System |
| Sub-Investigator: | James DLock | Stanford University |
| Principal Investigator: | Katherine Halmi | Department of Psychiatry, Cornell University |
| Principal Investigator: | Walter HKaye | UCSD Center for Eating Disorder Treatment & Research |
More Information
| Responsible Party: | Stanford University School of Medicine ( James D Lock, MD ) |
| Study ID Numbers: | SU-12132007-933, 5 U01 MH076290; SPO#33857 |
| Study First Received: | January 25, 2008 |
| Last Updated: | March 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00610753 History of Changes |
| Health Authority: | US:U.S: Institutional Review Board |
|
Signs and Symptoms Signs and Symptoms, Digestive Mental Disorders |
Anorexia Anorexia Nervosa Eating Disorders |
