This trial is evaluating whether Varenicline will improve 1 primary outcome and 1 secondary outcome in patients with Manic Disorder. Measurement will happen over the course of Through completion of study, an average of 2 years.
This trial requires 60 total participants across 2 different treatment groups
This trial involves 2 different treatments. Varenicline is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
"Manic disorder is a mental disorder that consists of a single manic episode plus at least two episodes (or persistent mood symptoms) for a minimum of seven days or greater, separated by at least 28 days without depressive symptoms. Although not all single episodes of mania are manic, some mood disorders such as bipolar disorder and mood dysregulated by medication are diagnosed as mania.\n" - Anonymous Online Contributor
"Treating MDA is difficult. Nevertheless, some MDA patients respond to treatment, and these respond equally to antidepressant, antipsychotic, or tricyclic antidepressant treatment. The effectiveness of the MDA treatment will depend on factors such as the duration and severity of the episodes and the initial response to the treatment." - Anonymous Online Contributor
"More than half of first-onset manic disorders are attributable to the medication or substance use. Many of the underlying mechanisms are unknown and the exact etiology of many of the first-onset manic disorders is unknown. Identifying the underlying cause of mania will be a key step in elucidating the cause of manic disorder." - Anonymous Online Contributor
"The lifetime prevalence of unipolar and bipolar II disorders in the United States is higher than previously estimated. Men have a higher rate of unipolar and bipolar II disorders than do women, and bipolar II disorder is significantly less common, although more severe, in women." - Anonymous Online Contributor
"Manic disorder can occur in children to young adults and can occur with or without a psychotic episode in between attacks. Treatment can include antidepressants, mood stabilisers or valproate. Treatment is highly dependent on the course of the disorder and on the response of the patient to the treatments. It is imperative that patients understand the long term consequences of their treatment and treatment should be maintained if possible." - Anonymous Online Contributor
"This answer: In a recent study, findings, we found that depressive episodes are common in out-patients with bipolar disorder. In the initial phase, the manic feature is less salient than a marked increase in depressive symptoms, or worsening mental status. However, by the third depressive episode, the symptoms resemble features of a mania or hypomania (except for the increased speed of speech, which may be more apparent in depressive episodes than in\nmany depressive features). Bipolar\ndisorder is an illness that can be associated with many syndromes." - Anonymous Online Contributor
"The authors concluded that the mood-stabilizing drugs lithium and valproate showed a high rate of efficacy as part of an initial mood-stabilizing regimen when monotherapy or adjunct therapy was begun. A few patients benefited from a prolonged mood stabilizer therapy of lamotrigine, valproate, or topiramate alone or in combination with each other. There is emerging data supporting the efficacy of lamotrigine and topiramate with or without valproate as a treatment for bipolar disorder. In the long term, there is no convincing evidence that atypical (non-medication) psychodynamic or psychosocial interventions are any more efficacious than mood stabilizers." - Anonymous Online Contributor
"This audit did not disclose any severe or life-threatening adverse events during 12 months of treatment with varenicline. Side effects were prevalent but few in number, and most were mild and transient. Most side effects were reported on the patients' self-report, and patients may have exaggerated or under-reported their symptomatology. The majority of adverse events reported by patients were mild or transient although some patients may have continued to use the product despite their symptoms. Given the common adverse events that may present as the first indication of a potential adverse effect, careful documentation and a regular review of symptomatology are essential." - Anonymous Online Contributor
"These data are consistent with a direct action of varenicline upon dopamine-releasing neurons. These data also suggest that a direct interaction between varenicline and α7-nAChRs might not be involved in its antidepressant effects." - Anonymous Online Contributor
"Treatment with varenicline is well tolerated. Its effectiveness for patients with MD is encouraging and adds to the evidence base for this medication in manic disorder." - Anonymous Online Contributor
"People with manic disorder tend to have a higher average age in which they experience a manic episode. Future studies examining the age of onset should further characterize this relationship." - Anonymous Online Contributor
"Varenicline may not be an effective therapy for PDM. A substantial subset of patients with PDM are not likely to benefit from treatment with varenicline." - Anonymous Online Contributor