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Study on the Optimal Strategy of Chinese Patients With Bulimia Nervosa After Fluoxetine Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154813
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
Huadong Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Jue CHEN, Shanghai Mental Health Center

Brief 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 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.

Condition or disease Intervention/treatment Phase
Fluoxetine Drug: Topiramate Drug: Fluoxetine Behavioral: cognitive behavioral therapy (CBT) Behavioral: dialectical behavior therapy (DBT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on the Optimal Strategy of Chinese Patients With Bulimia Nervosa After Fluoxetine Treatment
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Topiramate group
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.
Drug: Topiramate
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.

Experimental: Fluoxetine+DBT group
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.
Drug: Fluoxetine
Fluoxetine was increased from 20mg/d to the target dose (60mg/d) or below the maximum tolerable dose within 2 weeks.

Behavioral: dialectical behavior therapy (DBT)
DBT psychotherapy,once a week for three months.

Experimental: Fluoxetine+CBT group
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.
Drug: Fluoxetine
Fluoxetine was increased from 20mg/d to the target dose (60mg/d) or below the maximum tolerable dose within 2 weeks.

Behavioral: cognitive behavioral therapy (CBT)
CBT psychotherapy, once a week for three months.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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. ]
    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.

  3. 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154813


Locations
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China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Mental Health Center
Huadong Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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Responsible Party: Jue CHEN, Director of clinical psychology, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04154813    
Other Study ID Numbers: BN001
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bulimia
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Topiramate
Fluoxetine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors