UMIN ID: UMIN000002109
Registered date:01/07/2009
An open-label clinical trial of dopamine agonists in treatment-resistant depression
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | depression |
| Date of first enrollment | 2009/07/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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. 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. 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. |
Outcome(s)
| Primary Outcome | 1. Hamilton Depression Rating Scale (HAM-D) 2. Montgomery Asberg Depression Rating Scale (MADRS) 3. Clinical Global Impression (CGI) |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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) |
Related Information
| Primary Sponsor | Department of Mental Disorder Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Health, Labor and Welfare Ministry |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 4-1-1, Ogawahigashi, Kodaira, Tokyo Japan |
| Telephone | |
| Affiliation | National Institute of Neuroscience, National Center of Neurology and Psychiatry Department of Mental Disorder Research |
| scientific contact | |
| Name | Hiroshi Kunugi |
| Address | 4-1-1, Ogawahigashi, Kodaira, Tokyo Japan |
| Telephone | |
| Affiliation | National Institute of Neuroscience, National Center of Neurology and Psychiatry Department of Mental Disorder Research |