UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The status of essential trace metals and the efficacy of zinc supplementation in depressive disorders
Title of the study (Brief title)	A study of the efficacy of zinc supplementation in depressive disorders
Region	Japan

Condition
Condition	depressive disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of zinc supplementation in patient with depressive disorders that are resistant to conventional treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum levels of elements Zn and Cu, albumin, and total protein. Body weight and HAM-D17 score. These will be measured at 0, 4, 8, 12 weeks.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administraion of polaprezinc, a zinc-containing product.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	Those with depressive disorders according to DSM-IV-TR criteria, who are considered to be resistant to conventional antidepressant treatment.
Key exclusion criteria	Suicidal score in HAM-D17 is greater than 2.
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Kudo
Organization	Osaka University Graduate School of Medicine
Division name	Department of Psychiatry
Address	2-2 Yamadaoka, Suita-shi, Osaka-fu 565-0871
TEL
Email

Public contact
Name of contact person
Organization	Osaka University Graduate School of Medicine
Division name	Department of Psychiatry
Address
TEL
Homepage URL
Email	kudo@psy.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine, Department of Psychiatry
Institute
Department

Funding Source
Organization	Zeria Pharmaceutical Company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 04 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 03 Month 01 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 06 Month 04 Day
Last modified on	2018 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004477