Phase 4
Completed N=93
Fluoxetine to Prevent Relapse and Enhance Psychological Recovery in Women With Anorexia Nervosa
Source: ClinicalTrials.gov NCT00288574 ↗Enrolled (actual)
93
Serious AEs
1.1%
Results posted
Jul 2016
Primary outcomePrimary: Proportion of Patients Remaining in Study at 1 Year — 0.265; 0.315 proportion of participants — p=0.57
◆ Published Evidence
Highly cited
392citations · ~20 / year
Fluoxetine after weight restoration in anorexia nervosa: a randomized controlled trial.
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.
Linked Publications
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Fluoxetine after weight restoration in anorexia nervosa: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Remaining in Study at 1 Year |
0.265; 0.315 | 0.57 |
| SECONDARY Change in Weight Per Month During Treatment |
-1.94; -2.14 | 0.75 |
| SECONDARY Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Anxiety Inventory (BAI) |
-0.70; -0.22 | 0.007 sig |
| SECONDARY Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Depression Inventory (BDI) |
0.12; 0.20 | 0.79 |
| SECONDARY Change Per Month in Psychological Symptoms During Treatment, Assessed With the Rosenberg Self-Esteem Scale (RSES). |
0.12; 0.07 | 0.69 |
| SECONDARY Change Per Month in Psychological Symptoms During Treatment, Assessed With the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). |
0.23; 0.31 | 0.78 |
| SECONDARY Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Drive for Thinness Subscale. |
-0.24; -0.81 | 0.19 |
| SECONDARY Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Bulimia Subscale. |
-0.11; 0.035 | 0.46 |
| SECONDARY Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Body Dissatisfaction Subscale. |
-0.24; -0.26 | 0.86 |
| SECONDARY Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Perfectionism Subscale. |
-0.037; 0.05 | 0.25 |
| SECONDARY Change Per Month in Psychological Symptoms During Treatment, Assessed With the Yale Brown Cornell Obsessive Compulsive Scale for Eating Disorders (YBC-EDS) |
-0.18; 0.028 | 0.26 |
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00288574) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.