NCT00518843

Brief Summary

The primary hypotheses are:

  • A procedurally distinct family therapy is an effective and essential way to reduce bingeing and purging in adolescents with BN, and leads to the long-term amelioration of bulimic symptoms.
  • Family therapy is an effective way to bring about meaningful improvements in family interaction.
  • Family therapy will produce significantly larger reductions in bulimic symptoms and improved family interaction in adolescents with BN compared to a control supportive psychotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

5.1 years

First QC Date

August 17, 2007

Last Update Submit

September 4, 2013

Conditions

Bulimia Nervosa

Keywords

binge eatingpurging

Outcome Measures

Primary Outcomes (1)

  • Binge eating and purging frequency measured by the Eating Disorder Examination

    28 days

Secondary Outcomes (1)

  • EDE Subscales

    28 days

Study Arms (2)

FBT-BN

EXPERIMENTAL

Family-based treatment

Behavioral: FBT-BN

SPT

ACTIVE COMPARATOR

Individual Supportive Psychotherapy

Behavioral: SPT

Interventions

FBT-BNBEHAVIORAL

Mobilizing parents to curtail binge eating and purging

FBT-BN
SPTBEHAVIORAL

Supportive the individual patient to explore factors that might underlie the eating disorder

SPT

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • DSM-IV criteria for bulimia nervosa or partial bulimia nervosa

You may not qualify if:

  • psychotic illness acute suicidality medical illness that impacts weight pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Bulimia NervosaBulimia

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Le Grange, PhD

    The University of Chiacgo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2007

First Posted

August 21, 2007

Study Start

April 1, 2001

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)