UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003706
Receipt No. R000004477
Scientific Title The status of essential trace metals and the efficacy of zinc supplementation in depressive disorders
Date of disclosure of the study information 2010/06/04
Last modified on 2018/06/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The status of essential trace metals and the efficacy of zinc supplementation in depressive disorders
Acronym A study of the efficacy of zinc supplementation in depressive disorders
Scientific Title The status of essential trace metals and the efficacy of zinc supplementation in depressive disorders
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Kudo
Organization Osaka University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 2-2 Yamadaoka, Suita-shi, Osaka-fu 565-0871
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2009 Year 03 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000004477

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.