Unique ID issued by UMIN | UMIN000021368 |
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Receipt number | R000024642 |
Scientific Title | An open trial of polaprezinc for binge eating |
Date of disclosure of the study information | 2016/03/06 |
Last modified on | 2019/05/31 10:18:18 |
An open trial of polaprezinc for binge eating
An open trial of polaprezinc for binge eating
An open trial of polaprezinc for binge eating
An open trial of polaprezinc for binge eating
Japan |
Bulimia nervosa
Binge-eating disorder
Psychosomatic Internal Medicine | Psychiatry |
Others
NO
To evaluate the efficacy and safety of polaprezinc in patients with binge eating.
To examine the changes in plasma concentrations of brain-derived neurotrophic factor (BDNF) before and after polaprezinc treatment.
Safety,Efficacy
Frequency of binge eating
[at baseline and at 4, 8, 12, and 16 weeks after intervention]
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)]
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
Polaprezinc 75 or 150 mg/day per os for 16 weeks.
18 | years-old | <= |
65 | years-old | >= |
Male and Female
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.
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.
35
1st name | Kensaku |
Middle name | |
Last name | Sakae |
Keieikai Yashio Hospital
Department of psychiatry
340-0802
1089 Tsurugasone, Yashio-shi, Saitama 340-0802, Japan
048-996-3034
yashiohp@nifty.com
1st name | Kensaku |
Middle name | |
Last name | Sakae |
Keieikai Yashio Hospital
Department of psychiatry
340-0802
1089 Tsurugasone, Yashio-shi, Saitama 340-0802, Japan
048-996-3034
yashiohp@nifty.com
Keieikai Yashio Hospital
None
Self funding
Department of Public Health and Environmental Medicine, The Jikei University School of Medicine
Ethics Committee of the Jikei University School of Medicine
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461, Japan
03-3433-1111(ext.2134)
rinri@jikei.ac.jp
NO
医療法人慶榮会 八潮病院(埼玉県)
医療法人慶榮会 友愛クリニック(埼玉県)
2016 | Year | 03 | Month | 06 | Day |
Unpublished
Completed
2016 | Year | 02 | Month | 29 | Day |
2016 | Year | 02 | Month | 29 | Day |
2016 | Year | 03 | Month | 07 | Day |
2019 | Year | 02 | Month | 23 | Day |
2016 | Year | 03 | Month | 06 | Day |
2019 | Year | 05 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024642
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