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

Primary Purpose

Fluoxetine

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Topiramate
Fluoxetine
cognitive behavioral therapy (CBT)
dialectical behavior therapy (DBT)
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fluoxetine

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Topiramate group

Fluoxetine+DBT group

Fluoxetine+CBT group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 28, 2019
Last Updated
September 14, 2021
Sponsor
Shanghai Mental Health Center
Collaborators
Huadong Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04154813
Brief Title
Study on the Optimal Strategy of Chinese Patients With Bulimia Nervosa After Fluoxetine Treatment
Official Title
Study on the Optimal Strategy of Chinese Patients With Bulimia Nervosa After Fluoxetine Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Huadong Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluoxetine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topiramate group
Arm Type
Experimental
Arm Description
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.
Arm Title
Fluoxetine+DBT group
Arm Type
Experimental
Arm Description
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.
Arm Title
Fluoxetine+CBT group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Topiramate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
Fluoxetine was increased from 20mg/d to the target dose (60mg/d) or below the maximum tolerable dose within 2 weeks.
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy (CBT)
Intervention Description
CBT psychotherapy, once a week for three months.
Intervention Type
Behavioral
Intervention Name(s)
dialectical behavior therapy (DBT)
Intervention Description
DBT psychotherapy,once a week for three months.
Primary Outcome Measure Information:
Title
Eating Disorder Examination-Self-Report Questionnaire Version(EDE-Q)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Eating Disorder Inventory(EDI-II)
Description
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.
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
Title
Beck Depression Inventory (BDI)
Description
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.
Time Frame
Evaluate the depression symptoms change from baseline at 1 month, 2 months, 3 months, 6 months and 12 months.
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Evaluate the anxiety symptoms change from baseline at 1 month, 2 months, 3 months, 6 months and 12 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jue Chen, Ph.D
Phone
021-34773549
Email
chenjue2088@163.com
First Name & Middle Initial & Last Name & Degree
Hui Han, Master
Phone
8615021050893
Email
hanhui1126@yeah.net

12. IPD Sharing Statement

Plan to Share IPD
No

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

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