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

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Mental Health Center
• Collaborators: Huadong Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Tongji Hospital, Tongji University School of Medicine
• Treatments: Fluoxetine; Topiramate

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.