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

NCT04154813 | Unknown

• 1 other identifier: BN001
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluoxetine

Outcome Measures

Primary Outcomes (1)

• 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.

  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）

  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)

  Evaluate the depression symptoms change from baseline at 1 month, 2 months, 3 months, 6 months and 12 months.

• Beck Anxiety Inventory (BAI)

  Evaluate the anxiety symptoms change from baseline at 1 month, 2 months, 3 months, 6 months and 12 months.

Study Arms (3)

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.

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.

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.

Drug: Fluoxetine; Behavioral: cognitive behavioral therapy (CBT)

Interventions

Topiramate 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.

Topiramate group

Fluoxetine DRUG

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

Fluoxetine+CBT group; Fluoxetine+DBT group

cognitive behavioral therapy (CBT) BEHAVIORAL

CBT psychotherapy, once a week for three months.

Fluoxetine+CBT group

dialectical behavior therapy (DBT) BEHAVIORAL

DBT psychotherapy,once a week for three months.

Fluoxetine+DBT group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Huadong Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Interventions

Topiramate; Fluoxetine; Cognitive Behavioral Therapy; Dialectical Behavior Therapy

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Propylamines; Amines; Organic Chemicals; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of clinical psychology

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 7, 2019
• Study Start: February 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)