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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002109
Receipt No. R000002559
Scientific Title An open-label clinical trial of dopamine agonists in treatment-resistant depression
Date of disclosure of the study information 2009/07/01
Last modified on 2012/06/25

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Basic information
Public title An open-label clinical trial of dopamine agonists in treatment-resistant depression
Acronym An open clinical trial of dopamine agonists in treatment-resistant depression
Scientific Title An open-label clinical trial of dopamine agonists in treatment-resistant depression
Scientific Title:Acronym An open clinical trial of dopamine agonists in treatment-resistant depression
Region
Japan

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

Objectives
Narrative objectives1 The present study is an open-label trial of dopamine agonists Cabergoline, Pramipexole and Ropinirole, all of which are currently used for the treatment of Parkinson Disease, in patients with treatment-resistant depression, and aims to make a protocol of randomized controlled trial by estimating the effect size and verifying the safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. Hamilton Depression Rating Scale (HAM-D)
2. Montgomery Asberg Depression Rating Scale (MADRS)
3. Clinical Global Impression (CGI)
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cabergoline will be added to the medication which the patients have been already taking at the time of their study participation. Cabergoline will be administered at 0.25 mg/day at first, 0.5mg/day at 2 week, and subsequently titrated up to 3mg/day when necessary.
Interventions/Control_2 Pramipexole will be added to the medication which the patients have been already taking at the time of their study participation. Pramipexole will be administered at 0.25 mg/day at first, 0.5mg/day at 2 week, and subsequently titrated up to 3mg/day when necessary.
Interventions/Control_3 Ropinirole will be added to the medication which the patients have been already taking at the time of their study participation. Ropinirole will be administered at 0.75 mg/day at first and subsequently titrated up to 9mg/day when necessary.
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients diagnosed as having depression based on Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
2) Patients whose score on Hamilton Depression Rating Scale (HAM-D) 21-item version is 15 points or more despite 6 weeks or more treatment with adequate dose of at least one SSRI (Paroxetine, Fluvoxamine, or Sertraline).
3) Patients who are able to give informed consent by their free will after understanding the content of this study.
Key exclusion criteria 1) Concomitant severe physical diseases
2) Pregnant women
3) Marked suicidal ideation as indexed by the three points or more on the "suicide" item of HAM-D
4) Comorbid other psychiatric disorders
5) Cardiac abnormalities assessed with ECG and echocardiography (only for Cabergoline group)
6) Patients who can result in serious outcomes by sleepiness including those who drive a car (for Pramipexole and Ropinirole groups)
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kunugi
Organization National Institute of Neuroscience, National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research
Zip code
Address 4-1-1, Ogawahigashi, Kodaira, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Institute of Neuroscience, National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research
Zip code
Address 4-1-1, Ogawahigashi, Kodaira, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Department of Mental Disorder Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Health, Labor and Welfare Ministry
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
2009 Year 07 Month 01 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 Completed
Date of protocol fixation
2009 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 07 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
2009 Year 06 Month 23 Day
Last modified on
2012 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002559

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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