Adjunctive agomelatine therapy in the treatment of acute bipolar II depression: a preliminary open label study
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PURPOSE: The circadian rhythm hypothesis of bipolar disorder (BD) suggests a role for melatonin in regulating mood, thus extending the interest toward the melatonergic antidepressant agomelatine as well as type I (acute) or II cases of bipolar depression. PATIENTS AND METHODS: Twenty-eight depressed BD-II patients received open label agomelatine (25 mg/bedtime) for 6 consecutive weeks as an adjunct to treatment with lithium or valproate, followed by an optional treatment extension of 30 weeks. Measures included the Hamilton depression scale, Pittsburgh Sleep Quality Index, the Clinical Global Impression Scale-Bipolar Version, Young Mania Rating Scale, and body mass index. RESULTS: Intent to treat analysis results demonstrated that 18 of the 28 subjects (64%) showed medication response after 6 weeks (primary study endpoint), while 24 of the 28 subjects (86%) responded by 36 weeks. When examining primary mood stabilizer treatment, 12 of the 17 (70.6%) valproate and six of the 11 (54.5%) lithium patients responded by the first endpoint. At 36 weeks, 14 valproate treated (82.4%) and 10 lithium treated (90.9%) subjects responded. At 36 weeks, there was a slight yet statistically significant (P = 0.001) reduction in body mass index and Pittsburgh Sleep Quality Index scores compared to respective baseline values, regardless of mood stabilizer/outcome. Treatment related drop-out cases included four patients (14.28%) at week 6 two valproate-treated subjects with pseudo-vertigo and drug-induced hypomania, respectively, and two lithium-treated subjects with insomnia and mania, respectively. Week 36 drop outs were two hypomanic cases, one per group. CONCLUSION: Agomelatine 25 mg/day was an effective and well-tolerated adjunct to valproate/lithium for acute depression in BD-II, suggesting the need for confirmation by future double blind, controlled clinical trials.
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Several studies correlated sleep deprivation to mood disorders via melatonin secretion impairments.
“In fact, several studies correlated the sleep deprivation to mood disorders via melatonin secretion impairments [282].”
From Oxidative Stress Implications in the Affective Disorders: Main Biomarkers, Animal Models Relevance, Genetic Perspectives, and Antioxidant Approaches (2016) · cites this paper as [282]
Considering the implications of melatonin in regulation of the circadian rhythm, melatonergic products have been noticed to have antidepressant capacity in depression encountered in shift workers.
“Moreover, considering the well-known implications of melatonin in regulation of the circadian rhythm, melatonergic products have been noticed to have antidepressant capacity in depression encountered in shift workers [282, 284].”
From Oxidative Stress Implications in the Affective Disorders: Main Biomarkers, Animal Models Relevance, Genetic Perspectives, and Antioxidant Approaches (2016) · cites this paper as [282]
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“been noticed to have antidepressant capacity in depression encountered in shift workers [282, 284].”
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- Authors
- Fornaro, M., McCarthy, M. J., De Berardis, D., Pasquale, D., Martino, Colicchio, Cattaneo, D'Angelo, Fornaro, P., & Tabaton
- Affiliations
- University of Catania (IT)
- University of California San Diego (US)
- University of Genoa (IT)
- Corresponding author
- Fornaro, Michele
- Venue
- Neuropsychiatric Disease and Treatment
- Publisher
- Informa UK Limited
- Published
- 2013-02
- Volume
- 9
- Pages
- 243
- ISSN
- 1176-6328 (ISSN-L)
- PMC
- PMC3575211
- OpenAlex
- W2040320169
- Cited by
- 67
- References
- 95
- Citations by year
- 2025: 3 · 2024: 4 · 2023: 4 · 2022: 5 · 2021: 6 · 2020: 2 · 2019: 4 · 2018: 9 · 2017: 2 · 2016: 6 · 2015: 11 · 2014: 6 · 2013: 5
- FWCI
- 6.64
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Neuropsychiatric Disease and Treatment (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Maternal Mental Health During Pregnancy and Postpartum
- Keywords
- agomelatine, bipolar II depression, adjunctive therapy, melatonin, lithium, valproic acid, mood stabilizers, sleep quality, body mass index, drug tolerability, hypomania
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