NCT00288574

Brief Summary

This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate of relapse of anorexia nervosa (AN) and enhancing the psychosocial and behavioral recovery of people who have been treated for AN.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_4

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

January 1, 2000

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
10.4 years until next milestone

Results Posted

Study results publicly available

July 11, 2016

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

5.3 years

First QC Date

February 6, 2006

Results QC Date

September 8, 2015

Last Update Submit

December 11, 2017

Conditions

Anorexia NervosaEating Disorders

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients Remaining in Study at 1 Year

    The primary outcome measure was the proportion of patients with AN successfully completing 1 year of treatment and maintaining \> 85% Ideal Body Weight.

    12 months

Secondary Outcomes (10)

  • Change in Weight Per Month During Treatment

    12 months

  • Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Anxiety Inventory (BAI)

    12 months

  • Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Depression Inventory (BDI)

    12 months

  • Change Per Month in Psychological Symptoms During Treatment, Assessed With the Rosenberg Self-Esteem Scale (RSES).

    12 months

  • Change Per Month in Psychological Symptoms During Treatment, Assessed With the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).

    12 months

  • +5 more secondary outcomes

Study Arms (2)

fluoxetine

EXPERIMENTAL

fluoxetine up to 80 mg per day

Drug: Fluoxetine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

FluoxetineDRUG
fluoxetine
PlaceboDRUG
Placebo

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meets DSM-IV criteria for anorexia nervosa (except the requirement for amenorrhea)
  • Successfully completed treatment at one of the study sites in an inpatient or day-program setting immediately prior to study entry (BMI remained at least 19 kg/m2 for two weeks)

You may not qualify if:

  • Currently taking any medications other than occasional lorazepam or zopiclone for anxiety or sleep disturbance
  • Previous serious adverse reactions to fluoxetine (e.g., allergy)
  • Currently at risk for suicide
  • Any medical condition requiring treatment with other psychotropic medication (except the occasional use of anti-anxiety medication)
  • Pregnant
  • Any serious medical illness besides the eating disorder
  • History of continuous illness (at a low weight with no periods of remission or return to normal functioning for more than 15 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute/Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Walsh BT, Kaplan AS, Attia E, Olmsted M, Parides M, Carter JC, Pike KM, Devlin MJ, Woodside B, Roberto CA, Rockert W. Fluoxetine after weight restoration in anorexia nervosa: a randomized controlled trial. JAMA. 2006 Jun 14;295(22):2605-12. doi: 10.1001/jama.295.22.2605.

    PMID: 16772623RESULT

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating DisordersDepression

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title
BT Walsh, MD
Organization
NYSPI
edru@nyspi.columbia.edu
646-774-8066

Study Officials

  • B. Timothy Walsh, MD

    New York State Psychiatric Institute/Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

  • Allan Kaplan, MD

    Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 8, 2006

Study Start

January 1, 2000

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

December 13, 2017

Results First Posted

July 11, 2016

Record last verified: 2017-12

Locations

US(1)