ArticleNeuropsychiatric disease and treatment2013
Adjunctive agomelatine therapy in the treatment of acute bipolar II depression: a preliminary open label study.
Article in Neuropsychiatric disease and treatment, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.
- Hypnotic and Melatonin/Melatonin-Receptor Agonist Treatment in Bipolar Disorder: A Systematic Review and Meta-Analysis.CNS drugs · 2022Pooled it
- Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.Bipolar disorders · 2018Guideline
- Addressing Psychiatric Symptoms in Wilson's Disease: Translational Overlap with Bipolar Disorder and Emerging Therapeutic Strategies.Journal of clinical medicine · 2025Article
- Antidepressants in Bipolar Depression: From Neurotransmitter Mechanisms to Clinical Challenges.Actas espanolas de psiquiatria · 2025Review
- A pre-post trial to examine biological mechanisms of the effects of time-restricted eating on symptoms and quality of life in bipolar disorder.BMC psychiatry · 2024Article
- Bipolar Disorder, Circadian Rhythm and Clock Genes.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2024Review
- A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder.BMC psychiatry · 2024Article
- Agomelatine: A Potential Multitarget Compound for Neurodevelopmental Disorders.Brain sciences · 2023Review
- Agomelatine: a potential novel approach for the treatment of memory disorder in neurodegenerative disease.Neural regeneration research · 2023Review
- Pharmacological Treatment of Bipolar Depression: A Review of Observational Studies.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Blue Light Blocking Treatment for the Treatment of Bipolar Disorder: Directions for Research and Practice.Journal of clinical medicine · 2022Review
- Article
- Advances toward precision medicine for bipolar disorder: mechanisms & molecules.Molecular psychiatry · 2021Review
- Reduced-Exertion High-Intensity Interval Training as a Novel Therapeutic Approach for Insomnia.Frontiers in psychiatry · 2021Article
- Pharmacological Manipulation of the Circadian Clock: A Possible Approach to the Management of Bipolar Disorder.CNS drugs · 2019Review
- Treating Circadian Rhythm Disruption in Bipolar Disorder.Current psychiatry reports · 2019Review
- Mitochondrial Agents for Bipolar Disorder.The international journal of neuropsychopharmacology · 2018Review
- Oxidative Stress Implications in the Affective Disorders: Main Biomarkers, Animal Models Relevance, Genetic Perspectives, and Antioxidant Approaches.Oxidative medicine and cellular longevity · 2016Review
- Agomelatine: an agent against anhedonia and abulia?Journal of neural transmission (Vienna, Austria : 1996) · 2015Review
- Agomelatine beyond borders: current evidences of its efficacy in disorders other than major depression.International journal of molecular sciences · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe 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
methodsTwenty-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.
resultsIntent 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.
conclusionAgomelatine 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.