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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00974038
Other study ID # 4819
Secondary ID
Status Completed
Phase N/A
First received September 9, 2009
Last updated October 25, 2012
Start date November 2006
Est. completion date February 2010

Study information

Verified date October 2012
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

We are interested in studying two different psychological treatments for eating disorders for adolescents (ages 12-18). The study is designed to help adolescents who are having problems with binge eating and/or purging. The treatment consists of 14 sessions of approximately one-hour each over about three months.


Description:

Interested adolescents will have a phone screen and then come in for an in-person psychiatric evaluation. If eligible and interested, they will be randomly assigned to 4 months of outpatient treatment (free of charge) that is either 1) cognitive-behavioral therapy or 2) supportive psychotherapy.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Female
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- Current or prior DSM IV diagnosis of Bulimia Nervosa or Sub-threshold Bulimia Nervosa (those who meet all DSM-IV criteria for BN, but engage in subjective binge-eating episodes and binge/purge at a frequency of at least once per week for 3 months, whereas meeting full DSM-IV criteria for BN requires binge eating and purging twice per week for 3 months)

- Major Depression

Exclusion Criteria:

- Diagnosis of bipolar disorder, current psychosis, drug or alcohol abuse in past 3 months, acute suicidal risk, major depression producing significant functional impairment, significant medical illness, weight outside of normal weight range.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
psychotherapy
1) cognitive-behavioral therapy or 2) supportive psychotherapy

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Binge-eating a purging (EDE scores) 1 year No
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