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

NCT ID: NCT04154813

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2022-11-30

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.

Conditions

Fluoxetine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Topiramate

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Fluoxetine

Intervention Type: DRUG

Fluoxetine was increased from 20mg/d to the target dose (60mg/d) or below the maximum tolerable dose within 2 weeks.

dialectical behavior therapy (DBT)

Intervention Type: BEHAVIORAL

DBT psychotherapy,once a week for three months.

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.

Group Type: EXPERIMENTAL

Fluoxetine

Intervention Type: DRUG

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)

Intervention Type: BEHAVIORAL

CBT psychotherapy, once a week for three months.

Interventions

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.

Intervention Type: DRUG

Fluoxetine

Fluoxetine was increased from 20mg/d to the target dose (60mg/d) or below the maximum tolerable dose within 2 weeks.

Intervention Type: DRUG

cognitive behavioral therapy (CBT)

CBT psychotherapy, once a week for three months.

Intervention Type: BEHAVIORAL

dialectical behavior therapy (DBT)

DBT psychotherapy,once a week for three months.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huadong Hospital

OTHER

Sponsor Role: collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Jue CHEN

Director of clinical psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jue Chen, Ph.D

Role: primary

chenjue2088@163.com

021-34773549

Hui Han, Master

Role: backup

hanhui1126@yeah.net

8615021050893

Other Identifiers

BN001

Identifier Type: -

Identifier Source: org_study_id