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Ramelteon bipolar

Atul R Mahableshwarkar, Joseph R Calabrese, Thomas A Macek, Kumar Budur, Adedeji Adefuye, Xinxin Dong, Elizabeth Hanson, Gary S Sachs
BACKGROUND: The optimal long-term management strategy for bipolar I disorder patients is not yet established. Evidence supports the rationale for circadian rhythm regulation to prevent mood episode relapse in bipolar patients. This study evaluated the efficacy and safety of a new sublingual formulation of the melatonin receptor agonist ramelteon (ramelteon SL) as adjunctive therapy in the maintenance treatment of bipolar I patients. METHODS: In a double-blinded trial in the United States and Latin America, adult bipolar I disorder patients stable for ≥ 8 weeks before baseline and with a mood episode 8 weeks to 9 months before screening, were randomized to once-daily ramelteon SL 0...
October 15, 2017: Journal of Affective Disorders
Hee Ryung Wang, Young Sup Woo, Won-Myong Bahk
This systematic review aims to investigate whether melatonin or melatonin agonists significantly attenuate metabolic side effects among psychiatric populations treated with atypical antipsychotics. Four randomized-controlled trials were identified through a comprehensive literature search using MEDLINE, EMBASE, and the Cochrane Library on 22 October 2015. These four trials (including three melatonin studies and one ramelteon study) included 138 patients, of whom 71 were treated with melatonin or ramelteon and 67 were treated with a placebo...
November 2016: International Clinical Psychopharmacology
S Dimitrakopoulos, G Konstantakopoulos
The treatment of bipolar disorder is a current challenge for clinicians and despite progress in psychopharmacology, options remain limited and results are often unsatisfactory. Current research focuses on finding new pharmaceutical agents for all phases of bipolar disorder, i.e. mania, bipolar depression and maintenance. Particularly, relapse prevention and longterm stabilization is a major therapeutic target. Combination treatment and polypharmacy are the most common choices concerning relapse prevention. Furthermore, during maintenance phase patients often experience residual mood symptoms, cognitive deficits and functional decline, which altogether illustrate the inadequate effectiveness of existing treatments and the need for new, targeted, effective and safe treatments for bipolar disorder...
July 2015: Psychiatrikē, Psychiatriki
Pierre Alexis Geoffroy, Bruno Etain, Jean-Arthur Micoulaud Franchi, Frank Bellivier, Philipp Ritter
Bipolar disorders (BD) present with abnormalities of circadian rhythmicity and sleep homeostasis, even during phases of remission. These abnormalities are linked to the underlying neurobiology of genetic susceptibility to BD. Melatonin is a pineal gland secreted neurohormone that induces circadian-related and sleep-related responses. Exogenous melatonin has demonstrated efficacy in treating primary insomnia, delayed sleep phase disorder, improving sleep parameters and overall sleep quality, and some psychiatric disorders like autistic spectrum disorders...
2015: Current Pharmaceutical Design
Edward R Norris, Karen Burke, Julia R Correll, Kenneth J Zemanek, Joel Lerman, Ralph A Primelo, Michael W Kaufmann
BACKGROUND: Abnormalities in circadian rhythms are prominent features of bipolar disorder. Disrupted circadian rhythms are associated with an increased risk of relapse in bipolar disorder. Normalizing the circadian rhythm pattern of bipolar patients may improve their sleep and lead to fewer mood exacerbations. This study evaluated adjunctive ramelteon for the treatment of insomnia and mood stability in euthymic bipolar patients. METHODS: Participants with euthymic bipolar disorder and sleep disturbances were randomized to receive adjunctive ramelteon or placebo in addition to their regular psychiatric medications for up to 24 weeks or until they experienced a relapse (defined as a depressed or manic event)...
January 10, 2013: Journal of Affective Disorders
Susan L McElroy, Erin L Winstanley, Brian Martens, Nick C Patel, Nicole Mori, Dianna Moeller, Jessica McCoy, Paul E Keck
This study evaluated the efficacy and tolerability of ramelteon in ambulatory bipolar I disorder with manic symptoms and insomnia. Twenty-one outpatients with bipolar I disorder by Diagnostic and Statistical Manual of Mental Disorders, fourth edition criteria with mild-to-moderate manic symptoms and sleep disturbance were randomized to receive either ramelteon (N=10) or placebo (N=11) in an 8-week, double-blind, fixed-dose (8 mg/day) study. Ramelteon and placebo had similar rates of reduction in ratings of symptoms of insomnia, mania, and global severity of illness...
January 2011: International Clinical Psychopharmacology
Charles B Schaffer, Linda C Schaffer, Amber R Miller, Evelyn Hang, Thomas E Nordahl
BACKGROUND: Insomnia in patients with bipolar disorder (BD) can cause distress, daytime dysfunction, cognitive impairment, worsening of hypomanic/manic symptoms and increased suicide risk. Physicians often prescribe hypnotics for BD patients with insomnia although no hypnotic has a specific FDA indication for this use. In this study, the patterns of use, efficacy and safety of five nonbenzodiazepine hypnotics (NBZHs) were assessed in a large group of outpatients with BD. METHOD: A chart review was performed for all older adolescents and adult BD outpatients in a private outpatient clinic...
February 2011: Journal of Affective Disorders
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