Ropinirole in the Treatment of Bipolar Depression
Status: | Completed |
---|---|
Conditions: | Depression, Psychiatric, Bipolar Disorder |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 64 |
Updated: | 4/19/2017 |
Start Date: | September 2005 |
End Date: | March 17, 2008 |
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy of Ropinirole in the Treatment of Depression in Bipolar Disorder
To demonstrate efficacy and safety of Requip in in treating bipolar depression.
This study is 8 weeks long, with an optional additional 8 weeks. The study is
placebo-controlled and patients are randomized to receive either ropinerol or placebo.
Changes in depression, anxiety and overall psychiatric symptoms will be monitored during
participation.
placebo-controlled and patients are randomized to receive either ropinerol or placebo.
Changes in depression, anxiety and overall psychiatric symptoms will be monitored during
participation.
Inclusion Criteria:
- Meet DSM-IV criteria for bipolar disorder
- Current MADRS score > 16
- Current MRS-SADS score < 10
- Prior to participation in this study, each subject must sign an informed consent.
- All patients will be required to also take at least one other mood-stabilizing agent,
defined as a standard agent (lithium, valproate, carbamazepine) or a novel
anticonvulsant agent (oxcarbazepine, gabapentin, topiramate). If patients are not
taking any of these agents on study initiation, they will be required to start one of
these agents at study initiation. Study inclusion criteria must be met after at least
2 weeks of treatment with one of these mood-stabilizing agents.
Exclusion Criteria:
- Any serious acute medical illness
- Any clinically serious evidence of suicidality or score of 3 or greater on suicide
item on MADRS scale
We found this trial at
2
sites
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
Click here to add this to my saved trials
Click here to add this to my saved trials