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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006556
Receipt No. R000007769
Scientific Title Adjunctive treatment with pramipexole for antipsychotic-induced hyperprolactinemia in patients with schizophrenia, Reserch for efficacy and tolerability.
Date of disclosure of the study information 2011/10/20
Last modified on 2014/08/25

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Basic information
Public title Adjunctive treatment with pramipexole for antipsychotic-induced hyperprolactinemia in patients with schizophrenia, Reserch for efficacy and tolerability.
Acronym Adjunctive treatment with pramipexole for antipsychotic-induced hyperprolactinemia.
Scientific Title Adjunctive treatment with pramipexole for antipsychotic-induced hyperprolactinemia in patients with schizophrenia, Reserch for efficacy and tolerability.
Scientific Title:Acronym Adjunctive treatment with pramipexole for antipsychotic-induced hyperprolactinemia.
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and tolerability of pramipexole in the treatment of antipsychotics-induced hyperprolactinemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum prolactin level, Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale
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 pramipexole
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
50 years-old >=
Gender Male and Female
Key inclusion criteria schizophrenic patients who developed symptomatic hyperprolactinemia while taking antipsychotics
Key exclusion criteria subjects were excluded if they had problems with thyroid function, renal function,liver function, gynecological problems, or other general illnesses.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ishitobi Makoto
Organization University of Fukui
Division name Department of Neuropsychiatry
Zip code
Address 23-3 Matsuokashimoaizuki,Eiheiji-Cho, Yoshida-Gun, Fukui 910-1193, Japan
TEL 0776-61-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Fukui
Division name Department of Neuropsychiatry
Zip code
Address 23-3 Matsuokashimoaizuki,Eiheiji-Cho, Yoshida-Gun, Fukui 910-1193, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Neuropsychiatry,University of Fukui
Institute
Department

Funding Source
Organization Scientific Research from the Japan Society for the Promotion of Science.
Organization
Division
Category of Funding 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
2011 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 17 Day
Last modified on
2014 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007769

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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