Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0012833 (dizziness)
 9,689 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Unipolar depression is a major cause of disability in developed societies. There is significant unmet need because existing treatments are neither as effective nor as free of adverse effects as we would hope. Agomelatine is a new antidepressant with a novel profile of pharmacological action. Its efficacy in major depression has been reported in short-term placebo-controlled trials and in direct head-to-head comparison with existing products. The pooling of data from the agomelatine short-term studies allows analysis of sub-groups within the study populations. There is a trend for a larger effect size to be seen with more severely ill patients as a consequence of placebo responses falling. Efficacy is also reported in the maintenance of effect seen after clinical response in a recently completed relapse prevention study, analysed initially after 6 months. What is unusual, certainly compared with the selective serotonin reuptake inhibitors (SSRIs) and venlafaxine, is the clear absence of an excess of early relapses soon after agomelatine withdrawal. This parallels the absence of an immediate withdrawal effect seen in the pattern of subjective symptoms in another study. It underlines the distinct and novel pharmacological properties of the product, and has evident clinical advantages for the patient. Agomelatine is well tolerated in other respects; only occasional dizziness emerges at significant rates higher than with placebo in the controlled data.
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PMID:Innovation translates into antidepressant effectiveness. 1875 77

(1) When an antidepressant is considered a necessary addition to psychological support in treating patients with depression, the first-line drug is a tricyclic such as clomipramine or a selective serotonin reuptake inhibitor (SSRI) such as paroxetine; (2) Agomelatine, a melatonin receptor agonist, is approved in the European Union for the treatment of depression; (3) Available evaluation does not include any clinical trials designed to compare the efficacy of agomelatine with that of a tricyclic or a selective serotonin reuptake inhibitor. Most data come from 7 placebo-controlled trials; (4) Agomelatine (25 mg/day) was statistically more effective (on a rating scale) than placebo in only 3 of these 7 trials. The clinical relevance of the score improvements is questionable. No data are available on the cure rate or on suicide prevention; (5) In one trial, increasing the daily dose from 25 mg to 50 mg provided no supplementary benefit; (6) A trial in 367 patients failed to show that agomelatine was any more effective than placebo in preventing new depressive episodes (29% after one year). In another trial including 339 patients, the relapse rate was statistically lower after 6 months on agomelatine (20.6%) than on placebo (41.4%); (7) Very high doeses of agomelatine are oncogenic in animals. The risk in humans is not known. Dizziness, gastrointestinal and cutaneous disorders have been observed. Agomelatine is probably hepatotoxic; (8) In summary, agomelatine has unproven efficacy and poorly documented adverse effects. It is better to continue to use older antidepressants such as tricyclics or serotonin reuptake inhibitors.
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PMID:Agomelatine: new drug. Adverse effects and no proven efficacy. 2002 May 62

Obsessive-compulsive disorder (OCD) is often the anxiety disorder that affects approximately 2% of the population. This disorder is associated with significant morbidity and dysfunction, and is included in the World Health Organization list of the ten most disabling medical illnesses. The therapeutic response of patients with OCD is relatively poor compared with that of other mental disorders. Pharmacological interventions for OCD have focused on modulating primarily serotonin function and secondarily dopamine neurotransmission. Augmentation treatment has been the subject of several studies in treatment-resistant obsessive compulsive disorder (OCD). We hypothesized that medications with a dual action on the melatoninergic and serotoninergic systems may be of use in treatment-resistant OCD. In this open label study we investigated the efficacy and safety of agomelatine augmentation in treatment-resistant OCD. Twelve patients, aged 18-50, fulfilling OCD criteria, having failed to respond to adequate treatment with a Serotonine Reuptake Inhibitor for at least 16 weeks, were assigned to receive agomelatine augmentation. Subjects were assessed with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), and were screened for treatment-emergent side effects at baseline and week 16 of treatment. We excluded patients with comorbid psychopathology, serious medical comorbidity, current or past history of substance abuse and severe personality disorders as well as patients receiving psychotherapy in addition to psychopharmacological treatment. Agomelatine augmentation lead to net improvement in Y-BOCS and its obsession and compulsion subscales after 16 weeks of treatment (all p<0.005). Agomelatine augmentation was well-tolerated and none of the patients dropped-out. Treatment-related adverse events were recorded as follows: (n, %): nausea: 1 (8.3%), headache 4 (33.3%), dizziness: 3 (25%) and somnolence: 2 (16.7%). The present case series study has several limitations due to its open-label design and the absence of a placebo or active control group. The small number of patients further limits the impact of our findings. The present case series study showed that a 16 week add-on treatment with agomelatine, achieved on average a 25% improvement in Y-BOCS in refractory to treatment OCD patients; side effects were mild, and none of the patients dropped out throughout the 16-week study period. Agomelatine could be efficacious and well tolerated as an augmenting agent in refractory to treatment OCD. The unique pharmacological profile of agomelatine and its dual action on serotoninergic and melatoninergic receptors may be of interest in this difficult-to-treat illness. Further controlled studies are warranted to explore the efficacy of agomelatine, as well as the potential role of circadian rhythm modulation both in the pathophysiology and treatment of OCD.
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PMID:Agomelatine augmentation in obsessive compulsive disorder: a preliminary report. 2536 61