Depressive Disorder, Major
Conditions
Brief summary
This is an 8 week study for patients who are currently taking antidepressant medication but not fully responding. Ropinirole CR would be taken in conjunction with current antidepressant medication. Patients come into the clinic once a week when starting on the medication and then once every other week for the remainder of the 8 weeks.
Detailed description
We hope to learn whether ropinirole CR (controlled release formulation) is safe and effective when taken with an antidepressant to reduce the symptoms of depression. Adults who have a diagnosis of major depression and are currently taking an adequate dose of antidepressant medication will be sought for participation. They will continue to take the antidepressant medication and will receive ropinirole CR, an investigational medication, for eight weeks during which information will be collected about mood and cognitive functioning.
Interventions
DRUGRopinirole CR
Sponsors
Duke University
GlaxoSmithKline
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 65 years old * Currently experiencing major depression * On at least an adequate dose of fluoxetine, paroxetine, sertraline, citalopram, escitalopram, venlafaxine, bupropion, mirtazapine or duloxetine for at least 6 weeks (monotherapy).
Exclusion criteria
1. Pregnant females or females of child bearing years not using adequate birth control in the opinion of the investigators * Known sensitivity to ropinirole * Significant medical conditions that would preclude safe participation in the study in the opinion of the investigators. * Significant abnormalities observed in screening laboratory evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HamD | — |
Secondary
| Measure | Time frame |
|---|---|
| MADRS | — |
Countries
United States
Outcome results
None listed