Table 2.
Agomelatine in Mood and Anxiety Conditions and More. Current Literature Evidences in Clinical Human Studies.
| Author, Date | Disorder | Method | N Patients | Dose/Range | Results | Side-Effects |
|---|---|---|---|---|---|---|
| Table 2 part a | ||||||
| Goodwin et al., (2009) | MDD | 24-week, placebo-controlled, randomized clinical trial | 339 (165 on agomelatine, 174 on placebo) | 25 or 50 mg/day | Agomelatine was efficacious in preventing major depressive episode (MDE) recurrence while withdrawal syndrome was almost absent (placebo comparable profile) | |
| Kennedy et al., (2008) | MDD | 12 weeks double-blind, multicenter study, comparison of sexual functioning, antidepressant efficacy and tolerability between agomelatine and venlafaxine | 137(agomelatine) and 140 (venlafaxine RP) | 50 mg/day ago, tritated to a target dose of 150 mg/day venlafaxine | Agomelatine showed antidepressant efficacy and a superior sexual side effect profile vs. venlafaxine XR | |
| Montejo et al., 2008 | Healthy volunteers | 8 weeks placebo-controlled study using PRSEXDQ-SALSEX scale to study sexual acceptability of ago compared with paroxetine | 92 | 25-50 mg/die ago 20 mg/die paroxetine | Sexual Dysfunction was significantly lower in ago group than in paroxetine group | None |
| Stein et al. (2008) | GAD | 12 weeks randomized, double-blind, placebo-controlled trial | 121 | 25-50 mg/die ago | Significant superiority of ago 25 to 50 as compared with placebo; clinical response, symptoms of insomnia and improvement in associated disability, were consistent with the efficacy of ago. | Any relevant |
| Calabrese et al., (2007) | Depressed Bipolar I co-medicated with lithium or valpromide | Open-label for a minimum of 6 weeks followed by an optional extension of up to an additional 46 weeks | 14(lithium) 7(valpromide) | 25 mg/day agomelatine | Effectiveness of agomelatine | Any relevant |
| Lemoine et al., (2007) | MDD | Placebo-controlled RCT: 2 arms, venlafaxine vs agomelatine | 332 | 25-50mg/day ago or 75-150mg/day venlafaxine (variable dose) | The 6 weeks antidepressant effect of agomelatine was similar to those of venlafaxine. Sleep quality (measured by LSEQ) was subjectively better among patients treated with agomelatine. | Few with venlafaxine (dizziness, nausea, vomiting, tremor etc…), almost any with ago |
| Lopes et al., (2007) | Non-REM sleep instability in MDD | Single-blinded | 15+15 | 25mg/day | Agomelatine improved NREM sleep phases | Out of study aims |
| Montgomery and Kasper (2007) | Severe Depression | Pooled analysis of 3 positive placebo-controlled studies | 357 (agomelatine) and 360 (placebo) | 25-50mg/day | Clearly effective | Any relevant |
| Olié and Kasper, (2007) | Moderate to severe MDD | 6 weeks, double-blind, placebo-controlled, parallel randomized, group study (variably doses) | 238 | 25mg/day (augmented to 50mg/ day after 2weeks of non-response) | Depressed and sleep items improved in moderate and severe depressed patients | Placebo comparable frequency and severity |
| Pjrek et al., (2007) | SAD | 14 weeks open study | 37 | 25 mg/day | Large percentage of patients experiencing sustained remission during the 14 weeks of this study | Only one adverse event: mild fatigue |
| Quera Salva et al., (2007) | MDD | Open-label, polysomnography (PSG), quantitative EEG | 15 | 25mg/day agomelatine for 6 weeks | Sleep efficiency increased and intra-sleep awakening progressively decreased | Any relevant |
| Kennedy and Emsley, (2006) | Current (monopolar) MDE | Placebo-controlled 6 weeks RCT | 212 | 25-50mg/day ago | Both doses resulted to be well tolerated and effective also in severe cases (50mg/day) | Any relevant |
| Table 2 part b | ||||||
| Montgomery et al., (2004) | MDD | RCT: patients treated for 12 weeks with paroxetine 20mg/day vs patients treated with ago 25mg/day for 12 weeks, were abruptly discontinued to placebo or continued their drug for 2 more weeks. | 192 | 20mg/day (paroxetine) or 25mg/day (ago) | Patients treated for 12 weeks with agomelatine and continued to 2 weeks on the same drug, showed similar discontinuation symptoms to those “continued” to placebo while the paroxetine discontinued group experienced more. | |
| Loo et al., (2003) | DSM-III-R diagnosed MDD | RCT | 14 inpatients+14 outpatients | 5-100mg/day ago | Acceptability, efficacy were confirmed both at 5 and 100mg/day doses. 5mg regimen offered best clinical outcome while 100mg/day resulted in greater side effects frequency and drop-outs | Any relevant |
| Loo et al., (2002) | MDD | 8 weeks double-blind, placebo-controlled dose range study; paroxetine was used as the study validator | 711 | 1 mg/die or 5 mg/die or 25 mg/die ago | Ago 25 mg/die is statistically more effective than placebo in MDD and alleviates the anxiety associated with depression. | Any relevant |
| Cajochen et al., (1997) | Healthy volunteers | Cross-over design, comparison of acute administration of melatonin vs agomelatine 5h prior to bed time. Sleep structure and EEG evaluations. | 8 young male students (23-32 years) | 5-100mg/day (melatonin/ ago) | A single early dose of melatonin or agomelatine increases REM sleep propensity and advances sleep termination without affecting NREM duration. | None |
| Kräuchi et al., (1997) | Healthy volunteers | Double-blind, placebo-controlled crossover. Administration of melatonin, agomelatine and placebo was compared with dim-light onset, distal and core body temperature registrations. | 8 | 5mg/day (melatonin), 5 or 100mg/day (agomelatine) | Dose-dependent administration of melatonin or agomelatine resulted in earlier regulation of the endogenous circadian nocturnal decline in core body temperature and circadian phase advance. | Out of study aims |