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Bipolar Disorder, Mania clinical trials

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NCT ID: NCT03065933 Terminated - Clinical trials for Bipolar Disorder, Mania

An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study

Start date: January 2012
Phase: Phase 4
Study type: Interventional

Clonidine has been reported to be effective in a variety of hyperadrenergic states, including mania. It is generally well-tolerated and does not result in the severe adverse effects that are associated with many antipsychotics and mood stabilizers used in the treatment of mania, such as weight gain and akathisia. There is some suggestion that clonidine may be particularly effective in a subset of refractory cases and in patients who cannot tolerate antipsychotic medications or lithium. The investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. Subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. Rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. Any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study. The investigators believe that studying as few as 10 subjects will give the investigators a sense as to whether the addition of clonidine is helpful in reducing manic symptoms and the rate of adverse effects is unacceptable. See below for study results and reason for termination after recruiting only five subjects.

NCT ID: NCT00665366 Completed - Clinical trials for Bipolar Disorder Mania

Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.