FluoxetineNCT04154813
Study on the Optimal Strategy of Chinese Patients With Bulimia Nervosa After Fluoxetine Treatment
A study testing Topiramate, Fluoxetine and cognitive behavioral therapy (CBT) in people with Fluoxetine, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Current treatment strategies for BN are limited. The total effective rate of pharmacotherapy and psychotherapy is only about 50%.The preliminary studies and clinical experience of this project indicate that :(1) fluoxetine, DBT and CBT were effective in controlling binge eating and purging behaviors in patients with… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Fluoxetine
- What is being tested?
- Topiramate, Fluoxetine and cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Have junior high school or above education level;
- Meet the diagnostic criteria of BN in DSM-5, body mass index (BMI)≥ 18.5kg /m2;
- Did not receive systematic nutrition treatment, psychiatric medication or any form of psychological treatment within 1 month before enrollment.
- Each patient must understand the nature of the study and sign an informed consent form.
Who cannot join
- those who meet DSM-5 except BN, such as substance abuse/dependence, depression, bipolar disorder, anxiety disorder, obsessive-compulsive disorder, high risk of suicide, strong destructive impulse or antisocial behavior;
- the patient has a serious primary or secondary physical disease, cognitive impairment, so that the patient can not complete the required symptom evaluation examination, psychological test;
- had received systematic nutritional treatment, individual and group psychotherapy;
- nearly 1 month to take neuroblockers, antidepressants, lithium, stimulants, antiepileptic drugs and other psychiatric drugs.
- for other reasons, the researchers considered it inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Jue Chen, Ph.D, 021-34773549, chenjue2088@163.com
Hui Han, Master, 8615021050893, hanhui1126@yeah.net
About this study
Current treatment strategies for BN are limited. The total effective rate of pharmacotherapy and psychotherapy is only about 50%.The preliminary studies and clinical experience of this project indicate that :(1) fluoxetine, DBT and CBT were effective in controlling binge eating and purging behaviors in patients with BN;(2) the short-term efficacy of fluoxetine group is better than DBT group ;(3) treatment with fluoxetine is more convenient and easier to be accepted by Chinese patient and Chinese doctors. BN patients who had poor response to fluoxetine with adequate dosage and duration would receive a secondary treatment, and randomly assigned to three groups: topiramate, fluoxetine +CBT, fluoxetine +DBT.This study was designed as a multicenter randomized controlled study, in which 550 patients with bulimia were enrolled. During 1year of follow-up, the onset time, short-term and long-term efficacy, duration of treatment and the cost of each treatment strategies would be observed and compared.
Read the detailed description
Bulimia nervosa (BN) is a kind of chronic mental disorder which is easy to relapse, characterized by repeated binge eating, compensatory behaviors to prevent weight gain and excessive attention to one's own weight and body shape. Current treatment strategies for BN are limited. The total effective rate of pharmacotherapy and psychotherapy is only about 50%. All countries have listed SSRI drugs (fluoxetine 60mg/d has the most evidence from studies, and it is the only drug which has regulatory approval for the treatment of BN by FDA) and cognitive behavioral therapy (CBT) as the first-line treatment for BN. Other commonly used treatments include topiramate and dialectical behavior therapy (DBT).The preliminary studies and clinical experience of this project indicate that :(1) fluoxetine, DBT and CBT were effective in controlling binge eating and purging behaviors in patients with BN;(2) the short-term efficacy of fluoxetine group is better than DBT group ;(3) treatment with fluoxetine is more convenient and easier to be accepted by Chinese patient and Chinese doctors. Based on these factors above, this study was designed using fluoxetine as the initial treatment. However, there is no evidence for patients who fail to respond to fluoxetine therapy to choose further treatment. As the result of fact, this study is proposed to adopt a two-stage sequential study design.BN patients who had poor response to fluoxetine with adequate dosage and duration would receive a secondary treatment, and randomly assigned to three groups: topiramate, fluoxetine +CBT, fluoxetine +DBT.This study was designed as a multicenter randomized controlled study, in which 550 patients with bulimia were enrolled. During 1year of follow-up, the onset time, short-term and long-term efficacy, duration of treatment and the cost of each treatment strategies would be observed and compared. Based on the comprehensive evaluation of the advantages and disadvantage of each strategies, an evidence-based optimal strategy could be formed. The factors influencing the initial therapeutic effect and sequential therapeutic effect of BN would also be explored. If the expected results are obtained, it will provide strong support for the formulation of optimal clinical treatment strategy for BN.
- Conditions
- Fluoxetine
- Being tested
- Topiramate, Fluoxetine, cognitive behavioral therapy (CBT), dialectical behavior therapy (DBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
The initial dose of 25mg/d is rapidly increased to the target dose (100mg/d) or below the maximum tolerable dose if the patient can tolerate it.
FluoxetineDrug
Fluoxetine was increased from 20mg/d to the target dose (60mg/d) or below the maximum tolerable dose within 2 weeks.
cognitive behavioral therapy (CBT)Behavioural
CBT psychotherapy, once a week for three months.
dialectical behavior therapy (DBT)Behavioural
DBT psychotherapy,once a week for three months.
| Study group | Role | What they receive |
|---|---|---|
| Topiramate group | Experimental | If fluoxetine doesn't work after 3 months, randomly assigned to 3 groups, one group is topiramate group.During this group the initial dose of 25mg/day is rapidly increased to the target dose (100mg/day) or below the maximum tolerable dose if the patient can tolerate it. Receives: Drug: Topiramate |
| Fluoxetine+DBT group | Experimental | If fluoxetine doesn't work after 3 months, randomly assigned to 3 groups, one group is fluoxetine+DBT group. Group cognitive behavioral therapy was performed while fluoxetine was maintained. Target dose of fluoxetine is 60mg/day.Treatment was divided into three stages: the initial stage, the main stage and the end stage. The treatment was conducted once a week for a total of 12 times, followed by maintenance treatment for 6 months. Receives: Drug: Fluoxetine; Behavioral: dialectical behavior therapy (DBT) |
| Fluoxetine+CBT group | Experimental | If fluoxetine doesn't work after 3 months, randomly assigned to 3 groups, one group is fluoxetine+CBT group.Target dose of fluoxetine is 60mg/day. DBT therapy was performed while the original fluoxetine dose was maintained.The core treatment stage was 1 time per week, 12 times in total, and 6 months of maintenance treatment followed. Receives: Drug: Fluoxetine; Behavioral: cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination-Self-Report Questionnaire Version（EDE-Q）
Has 41-item measure adapted from the Eating Disorder Examination (EDE), and four subscales of the EDE-Q: Restraint, Weight Concern, Shape Concern, and Eating Concern.
Measured: Change from baseline the frequency of binge eating and clearing behaviors at 1 month, 2 months, 3 months, 6 months and 12 months.
Secondary outcomes (3)
Eating Disorder Inventory（EDI-II）
The EDI is a 64 item, self-report, multiscale measure designed for the assessment of psychological and behavioral traits common in eating disorder. The EDI consists of eight sub-scales measuring: 1) Drive for Thinness, 2) Bulimia, 3) Body Dissatisfaction, 4) Ineffectiveness, 5) Perfectionism, 6) Interpersonal Distrust, 7) Interoceptive Awareness and 8) Maturity Fears.
Measured: To evaluate the eating behavior and psychological changes of BN patients during treatment.1 month, 2 months, 3 months, 6 months, 12 months
Beck Depression Inventory (BDI)
use self-rating scale for depression, including 21 items of subjects such as emotional state, interests and hobbies, sleep quality, energy and spirit, and suicide risk.
Measured: Evaluate the depression symptoms change from baseline at 1 month, 2 months, 3 months, 6 months and 12 months.
Beck Anxiety Inventory (BAI)
BAI has 21 self-assessment items, and subjects' degree of being bothered by various anxiety symptoms is taken as the assessment index, and the method of 4 grades is adopted.Its standard is "1" means none;"2" means mild, not much trouble;"3" means moderate, uncomfortable but tolerable;"4" means heavy, barely tolerable.
Measured: Evaluate the anxiety symptoms change from baseline at 1 month, 2 months, 3 months, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Feb 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FluoxetineStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- There is no evidence for patients who fail to respond to fluoxetine therapy to choose further treatment. As the result of fact, this study is proposed to adopt a two-stage sequential study design.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Jue CHEN, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154813
- Sponsor's protocol ID
- BN001
- Status last verified
- Sep 2021
- First submitted
- 28 Oct 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Optimal Strategy of Chinese Patients With Bulimia Nervosa After Fluoxetine Treatment
- ClinicalTrials.gov ID
- NCT04154813
- Acronym / sponsor ID
- BN001
- Conditions
- Fluoxetine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Huadong Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current treatment strategies for BN are limited. The total effective rate of pharmacotherapy and psychotherapy is only about 50%.The preliminary studies and clinical experience of this project indicate that :(1) fluoxetine, DBT and CBT were effective in controlling binge eating and purging behaviors in patients with BN;(2) the short-term efficacy of fluoxetine group is better than DBT group ;(3) treatment with fluoxetine is more convenient and easier to be accepted by Chinese patient and Chinese doctors. BN patients who had poor response to fluoxetine with adequate dosage and duration would receive a secondary treatment, and randomly assigned to three groups: topiramate, fluoxetine +CBT, fluoxetine +DBT.This study was designed as a multicenter randomized controlled study, in which 550 patients with bulimia were enrolled. During 1year of follow-up, the onset time, short-term and long-term efficacy, duration of treatment and the cost of each treatment strategies would be observed and compared.
Detailed description
Bulimia nervosa (BN) is a kind of chronic mental disorder which is easy to relapse, characterized by repeated binge eating, compensatory behaviors to prevent weight gain and excessive attention to one's own weight and body shape. Current treatment strategies for BN are limited. The total effective rate of pharmacotherapy and psychotherapy is only about 50%. All countries have listed SSRI drugs (fluoxetine 60mg/d has the most evidence from studies, and it is the only drug which has regulatory approval for the treatment of BN by FDA) and cognitive behavioral therapy (CBT) as the first-line treatment for BN. Other commonly used treatments include topiramate and dialectical behavior therapy (DBT).The preliminary studies and clinical experience of this project indicate that :(1) fluoxetine, DBT and CBT were effective in controlling binge eating and purging behaviors in patients with BN;(2) the short-term efficacy of fluoxetine group is better than DBT group ;(3) treatment with fluoxetine is more convenient and easier to be accepted by Chinese patient and Chinese doctors. Based on these factors above, this study was designed using fluoxetine as the initial treatment. However, there is no evidence for patients who fail to respond to fluoxetine therapy to choose further treatment. As the result of fact, this study is proposed to adopt a two-stage sequential study design.BN patients who had poor response to fluoxetine with adequate dosage and duration would receive a secondary treatment, and randomly assigned to three groups: topiramate, fluoxetine +CBT, fluoxetine +DBT.This study was designed as a multicenter randomized controlled study, in which 550 patients with bulimia were enrolled. During 1year of follow-up, the onset time, short-term and long-term efficacy, duration of treatment and the cost of each treatment strategies would be observed and compared. Based on the comprehensive evaluation of the advantages and disadvantage of each strategies, an evidence-based optimal strategy could be formed. The factors influencing the initial therapeutic effect and sequential therapeutic effect of BN would also be explored. If the expected results are obtained, it will provide strong support for the formulation of optimal clinical treatment strategy for BN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- There is no evidence for patients who fail to respond to fluoxetine therapy to choose further treatment. As the result of fact, this study is proposed to adopt a two-stage sequential study design.
| Arm | Type | Receives |
|---|---|---|
| Topiramate group | Experimental | Drug: TopiramateIf fluoxetine doesn't work after 3 months, randomly assigned to 3 groups, one group is topiramate group.During this group the initial dose of 25mg/day is rapidly increased to the target dose (100mg/day) or below the maximum tolerable dose if the patient can tolerate it. |
| Fluoxetine+DBT group | Experimental | Drug: Fluoxetine, Behavioral: dialectical behavior therapy (DBT)If fluoxetine doesn't work after 3 months, randomly assigned to 3 groups, one group is fluoxetine+DBT group. Group cognitive behavioral therapy was performed while fluoxetine was maintained. Target dose of fluoxetine is 60mg/day.Treatment was divided into three stages: the initial stage, the main stage and the end stage. The treatment was conducted once a week for a total of 12 times, followed by maintenance treatment for 6 months. |
| Fluoxetine+CBT group | Experimental | Drug: Fluoxetine, Behavioral: cognitive behavioral therapy (CBT)If fluoxetine doesn't work after 3 months, randomly assigned to 3 groups, one group is fluoxetine+CBT group.Target dose of fluoxetine is 60mg/day. DBT therapy was performed while the original fluoxetine dose was maintained.The core treatment stage was 1 time per week, 12 times in total, and 6 months of maintenance treatment followed. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Have junior high school or above education level;
- Meet the diagnostic criteria of BN in DSM-5, body mass index (BMI)≥ 18.5kg /m2;
- Did not receive systematic nutrition treatment, psychiatric medication or any form of psychological treatment within 1 month before enrollment.
- Each patient must understand the nature of the study and sign an informed consent form.
Key exclusion criteria (5 listed)
- those who meet DSM-5 except BN, such as substance abuse/dependence, depression, bipolar disorder, anxiety disorder, obsessive-compulsive disorder, high risk of suicide, strong destructive impulse or antisocial behavior;
- the patient has a serious primary or secondary physical disease, cognitive impairment, so that the patient can not complete the required symptom evaluation examination, psychological test;
- had received systematic nutritional treatment, individual and group psychotherapy;
- nearly 1 month to take neuroblockers, antidepressants, lithium, stimulants, antiepileptic drugs and other psychiatric drugs.
- for other reasons, the researchers considered it inappropriate to participate in this clinical trial.
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 |
|---|---|---|
| TopiramateThe initial dose of 25mg/d is rapidly increased to the target dose (100mg/d) or below the maximum tolerable dose if the patient can tolerate it. | Drug | Topiramate group |
| FluoxetineFluoxetine was increased from 20mg/d to the target dose (60mg/d) or below the maximum tolerable dose within 2 weeks. | Drug | Fluoxetine+CBT group, Fluoxetine+DBT group |
| cognitive behavioral therapy (CBT)CBT psychotherapy, once a week for three months. | Behavioural | Fluoxetine+CBT group |
| dialectical behavior therapy (DBT)DBT psychotherapy,once a week for three months. | Behavioural | Fluoxetine+DBT group |
Primary outcome
Eating Disorder Examination-Self-Report Questionnaire Version（EDE-Q）
Time frame: Change from baseline the frequency of binge eating and clearing behaviors at 1 month, 2 months, 3 months, 6 months and 12 months.
Has 41-item measure adapted from the Eating Disorder Examination (EDE), and four subscales of the EDE-Q: Restraint, Weight Concern, Shape Concern, and Eating Concern.
3 secondary outcomes
Eating Disorder Inventory（EDI-II）
Time frame: To evaluate the eating behavior and psychological changes of BN patients during treatment.1 month, 2 months, 3 months, 6 months, 12 months
Beck Depression Inventory (BDI)
Time frame: Evaluate the depression symptoms change from baseline at 1 month, 2 months, 3 months, 6 months and 12 months.
Beck Anxiety Inventory (BAI)
Time frame: Evaluate the anxiety symptoms change from baseline at 1 month, 2 months, 3 months, 6 months and 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topiramate, Fluoxetine and cognitive behavioral therapy (CBT) in people with Fluoxetine, run by Shanghai Mental Health Center at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination-Self-Report Questionnaire Version（EDE-Q） (time frame: Change from baseline the frequency of binge eating and clearing behaviors at 1 month, 2 months, 3 months, 6 months and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2021.