Bulimia nervosa Binge-eating disorder
Conditions
Interventions
Polaprezinc 75 or 150 mg/day per os for 16 weeks.
Sponsors
Keieikai Yashio Hospital
Department of Public Health and Environmental Medicine, The Jikei University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Currently meets DSM-V criteria for bulimia nervosa or binge-eating disorder despite receiving antidepressant treatment for at least 8 weeks; and 2. Is able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Has a history of a personality disorder that may interfere with assessment or adherence to study procedures; 2. Is at serious suicidal risk; 3. Has a clinically unstable medical illness; 4. Is pregnant, planning on becoming pregnant during the study period, or lactating; 5. Receiving cognitive-behavioral or interpersonal therapy; and 6. Has received polaprezinc in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of binge eating [at baseline and at 4, 8, 12, and 16 weeks after intervention] | — |
Secondary
| Measure | Time frame |
|---|---|
| EDE-Q QIDS-SR16 Body weight Biochemistry [at baseline and at 4, 8, 12, and 16 weeks after intervention] Plasma concentrations of BDNF [at baseline and at 16 weeks after intervention (or endpoint of study)] | — |
Countries
Japan
Contacts
Public ContactKensaku Sakae
Keieikai Yashio Hospital Department of psychiatry
Outcome results
None listed