UMIN-CTR Clinical Trial

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

depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Health, Labor and Welfare Ministry

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2009

Year

06

Month

23

Day

Last modified on

2012

Year

06

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002559