Anorexia NervosaPhase 4NCT00288574
Fluoxetine to Prevent Relapse and Enhance Psychological Recovery in Women With Anorexia Nervosa
A Phase 4 study testing Fluoxetine in people with Anorexia Nervosa and Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Anorexia Nervosa, Eating Disorders
- What is being tested?
- Fluoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to May 2005
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute/Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Fluoxetine After Weight Restoration in Anorexia Nervosa
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.
Read the detailed description
Anorexia nervosa (AN), a type of eating disorder, is a serious psychiatric illness that is characterized by an extreme loss of appetite. People with AN view themselves as overweight and cannot bring themselves to eat, even though most are dangerously thin. Signs of the disorder include unusual eating habits, such as avoiding food and meals, picking out a few foods and eating them in small quantities, or carefully weighing and portioning food. Some people with AN fully recover after a single episode, some have a fluctuating pattern of weight gain and relapse, and others experience a chronic course of illness over many years. Effective drugs to treat the disorder are lacking. In addition, most past research has examined the effect of medications during the initial phase of treatment, a time when AN patients may not respond to medication because of the acute effects of starvation. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that is commonly used to treat depression. This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate of relapse of AN and enhancing the psychosocial and behavioral recovery of women who have already been treated for AN.
Participants in this double-blind study will be recruited immediately following completion of a treatment program for AN, in which they maintained a body mass index (BMI) of at least 19 kg/m2 for two weeks. Upon study entry, participants will be randomly assigned to receive either fluoxetine or placebo for 12 months. Participants will begin receiving medication one week prior to discharge from the hospital in which they received care for AN. Medication doses will be increased up to a target dose of 60 mg per day, and will not exceed 80 mg per day. Participants will receive 50 sessions of cognitive-behavioral therapy, lasting approximately 45 minutes each and occurring twice weekly for the first month following discharge from the hospital. After the first month, therapy sessions will occur once weekly until Month 9 and then every other week until Month 12. Participants will also report to the study site to meet with a psychiatrist once a week for the first month following discharge and then every other week for the remainder of the study. General medical status, evidence of AN relapse, medication dose, and side effects will be assessed at these visits. Upon completing treatment, follow-up telephone calls will occur at Months 15 and 21, and follow-up visits will be held at Months 18 and 24. Psychopathology associated with AN, including concern with weight and shape, depressive symptoms, anxiety, and obsessive behavior, will be assessed.
- Conditions
- Anorexia Nervosa, Eating Disorders
- Being tested
- Fluoxetine, Placebo
- Keywords
- Depression
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| fluoxetine | Experimental | fluoxetine up to 80 mg per day Receives: Drug: Fluoxetine |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (10)
Change in Weight Per Month During Treatment
Measured: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory is a 21 question self-report measure of anxiety symptoms during the past week. Possible scores range from 0 - 63, with higher scores indicating more severe symptoms. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.
Measured: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Depression Inventory (BDI)
The Beck Depression Inventory-II is a 21 question self-report measure of depressive symptoms. Possible scores range from 0 - 63, with higher scores indicating more severe symptoms.Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.
Measured: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Rosenberg Self-Esteem Scale (RSES).
The RSES is a 10 item self-report measure of self-esteem. Possible scores range from 0 - 30, with lower scores indicating more severe symptoms. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.
Measured: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
The Q-LES-Q is a 93 item self-report measure of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. Each of the 93 items is scored on a five-point scale, and the total score is converted to a percentage of the maximum score possible. The range is therefore from 0 to 100, with a higher score indicating greater enjoyment or satisfaction. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.
Measured: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Drive for Thinness Subscale.
The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Drive for Thinness subscale is comprised of seven items indicating excessive concern with dieting, preoccupation with weight and entrenchment in an extreme pursuit of thinness. Possible scores range from 0 to 21, with higher scores indicating greater Drive for Thinness. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.
Measured: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Bulimia Subscale.
The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Bulimia subscale is comprised of seven items indicating the tendency towards episodes of uncontrollable overeating (binge eating). Possible scores range from 0 to 21, with higher scores indicating greater tendency. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.
Measured: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Body Dissatisfaction Subscale.
The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Body Dissatisfaction subscale is comprised of nine items indicating the belief that parts of the body are too large. Possible scores range from 0 to 27, with higher scores indicating greater dissatisfaction. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.
Measured: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Perfectionism Subscale.
The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Perfectionism subscale is comprised of six items Indicating excessive personal expectations for superior achievement. Possible scores range from 0 to 18, with higher scores indicating greater expectations. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.
Measured: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Yale Brown Cornell Obsessive Compulsive Scale for Eating Disorders (YBC-EDS)
The YBC-EDS is an eight item, clinician-rated instrument assessing eating related preoccupations and/or rituals. Possible scores range from 0 to 32, with higher scores indicating greater preoccupations. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startJan 2000
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- B. Timothy Walsh, MD, Principal investigator, New York State Psychiatric Institute/Columbia University Medical CenterAllan Kaplan, MD, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288574
- Sponsor's protocol ID
- #4703R
- Other IDs
- R01MH060271, R01MH060336, DSIR AT-P
- Status last verified
- Dec 2017
- First submitted
- 6 Feb 2006
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 16772623
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoxetine After Weight Restoration in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00288574
- Acronym / sponsor ID
- #4703R
- Conditions
- Anorexia Nervosa, Eating Disorders
- Keywords
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2000
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 8 Feb 2006 (estimated)
- Results
- Posted 11 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anorexia nervosa (AN), a type of eating disorder, is a serious psychiatric illness that is characterized by an extreme loss of appetite. People with AN view themselves as overweight and cannot bring themselves to eat, even though most are dangerously thin. Signs of the disorder include unusual eating habits, such as avoiding food and meals, picking out a few foods and eating them in small quantities, or carefully weighing and portioning food. Some people with AN fully recover after a single episode, some have a fluctuating pattern of weight gain and relapse, and others experience a chronic course of illness over many years. Effective drugs to treat the disorder are lacking. In addition, most past research has examined the effect of medications during the initial phase of treatment, a time when AN patients may not respond to medication because of the acute effects of starvation. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that is commonly used to treat depression. This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate of relapse of AN and enhancing the psychosocial and behavioral recovery of women who have already been treated for AN.
Participants in this double-blind study will be recruited immediately following completion of a treatment program for AN, in which they maintained a body mass index (BMI) of at least 19 kg/m2 for two weeks. Upon study entry, participants will be randomly assigned to receive either fluoxetine or placebo for 12 months. Participants will begin receiving medication one week prior to discharge from the hospital in which they received care for AN. Medication doses will be increased up to a target dose of 60 mg per day, and will not exceed 80 mg per day. Participants will receive 50 sessions of cognitive-behavioral therapy, lasting approximately 45 minutes each and occurring twice weekly for the first month following discharge from the hospital. After the first month, therapy sessions will occur once weekly until Month 9 and then every other week until Month 12. Participants will also report to the study site to meet with a psychiatrist once a week for the first month following discharge and then every other week for the remainder of the study. General medical status, evidence of AN relapse, medication dose, and side effects will be assessed at these visits. Upon completing treatment, follow-up telephone calls will occur at Months 15 and 21, and follow-up visits will be held at Months 18 and 24. Psychopathology associated with AN, including concern with weight and shape, depressive symptoms, anxiety, and obsessive behavior, will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluoxetine | Experimental | Drug: Fluoxetinefluoxetine up to 80 mg per day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoxetine | Drug | fluoxetine |
| Placebo | Drug | Placebo |
Primary outcome
Proportion of Patients Remaining in Study at 1 Year
Time frame: 12 months
The primary outcome measure was the proportion of patients with AN successfully completing 1 year of treatment and maintaining > 85% Ideal Body Weight.
10 secondary outcomes
Change in Weight Per Month During Treatment
Time frame: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Anxiety Inventory (BAI)
Time frame: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Depression Inventory (BDI)
Time frame: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Rosenberg Self-Esteem Scale (RSES).
Time frame: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Time frame: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Drive for Thinness Subscale.
Time frame: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Bulimia Subscale.
Time frame: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Body Dissatisfaction Subscale.
Time frame: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Perfectionism Subscale.
Time frame: 12 months
Change Per Month in Psychological Symptoms During Treatment, Assessed With the Yale Brown Cornell Obsessive Compulsive Scale for Eating Disorders (YBC-EDS)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16772623Walsh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B. Timothy Walsh, MD principal investigator
New York State Psychiatric Institute/Columbia University Medical Center
Allan Kaplan, MD principal investigator
Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoxetine in people with Anorexia Nervosa and Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Remaining in Study at 1 Year (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00288574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.