STABLON can be prescribed in all types of adult patients with major depression. STABLON is actually effective in major depression, whether mild, moderate, or even severe, with or without melancholic characteristics. In patients presenting with recurrent depression, STABLON versus placebo effectively prevented depression relapse and recurrence over 18 months.

Its unique clinical characteristics make STABLON particularly useful in young active depressed patients. STABLON alleviates anxious symptoms of depression, which are frequent in depressed patients. This effect is free of sedation. Thus, STABLON preserves daytime awareness and is compatible with patients' professional activities.

In practice, STABLON gives depressed patients rapid and effective relief, but also helps them resume an active and normal professional and family life.

Clinician global judgment indicates that, from the first week of treatment, there are significantly more improved patients on STABLON than on fluoxetine. This difference is confirmed in the second week of treatment. More precisely, at the very beginning of the treatment with STABLON, improvement will be particularly notable for the frequent symptoms of inner tension and concentration difficulties.

This early improvement with STABLON constitutes a clear advantage for depressed patients. STABLON improves early markers of neuroplasticity. This allows better understanding of rapid improvement in depressed patients, STABLON helps them to rapidly resume an active daily life.

STABLON very considerably reduces the risk of depressive relapse and recurrence. Over a 18-month follow-up period, 16% of patients relapsed with STABLON versus 36% with the placebo.

Even in the longer term, STABLON protects patients against depressive relapse and recurrence over 18 months. There were 4 times fewer relapses in patients treated by STABLON: 84% of patients without any new depressive episode.

This is another reason why STABLON, and its unique impact on neuroplasticity, help protect young depressed patients and expedite their return to a normal family and professional life.

Anxiety symptoms are often present in patients suffering from major depression, and are associated with a worse quality of life of depressed patients. Anxiety in depression is associated with an increase in the duration of the depressive episode, and with a decreased response to antidepressant drug therapy. The addition of an anxiolytic drug to the antidepressant treatment is often necessary to relieve anxious symptoms in depressed patients. Nevertheless, untoward side effects associated with benzodiazepines have led health authorities in many countries to limit their use to the short-term relief of anxiety.

Few antidepressants are associated with rapid relief of anxiety symptoms of depression, but for most drugs relief seems to be the consequence of sedative side effects due, for instance, to their antihistaminic properties. STABLON alleviates anxious symptoms of depression. This effect is free of sedation.

Clinical trials evaluating the antidepressant efficacy of STABLON have shown that it alleviates anxiety symptoms of depression. STABLON was shown to be as efficient as a benzodiazepine, alprazolam, and mianserin, an antidepressant in the relief of anxious symptoms.

There is a significantly decreased requirement for a concomitant anxiolytic on therapy with STABLON versus therapy with fluoxetine. Anxiolytic use decreases by 50% in patients treated with STABLON.

STABLON reduces inner tension significantly more rapidly than fluoxetine. The effect of STABLON on anxious symptoms is free of sedation, and STABLON shows a total absence of adverse effects on the ability of healthy volunteer to drive.

As with other depressed patients, STABLON can be prescribed in cases of alcoholism, and more specifically during the withdrawal period because of its efficacy and remarkable acceptability.

A multicenter double-blind trial versus amitriptyline lasting 1 to 2 months was undertaken in 129 alcoholics undergoing withdrawal in whom depression and its course were evaluated using standardized rating scales. Patients took three tablets per day of tianeptine or amitriptyline.¹

Analysis of results revealed the statistically significant efficacy of STABLON concerning all of the symptoms and signs so frequently encountered in alcoholics during withdrawal. STABLON relieved anxiety, acted against depression, soothed psychological suffering, and decreased the somatic manifestations of anxiety, while leaving alertness and sleep unimpaired. The therapeutic activity of STABLON and its safety/acceptability, superior to that of amitriptyline, would explain the very good treatment compliance in these patients, known for their tendency to rapidly abandon any prescribed medication.

These results confirm those obtained earlier in controlled trials versus reference antidepressants in alcoholics suffering from depression during and after withdrawal.^2,3

An open trial of 130 depressed patients following alcoholic withdrawal demonstrated the antidepressant efficacy of STABLON, significant by the 14th day and persistent at each time of evaluation, emphasized by the patients themselves and strengthening over the course of time. Particular mention should be made of the low percentage of trial dropouts, bearing in mind the difficulties encountered in the management of such patients. 47% of patients included were treated for 1 year.⁴

It is important to note that the pharmacokinetic parameters characterized in the distribution and elimination of tianeptine are statistically similar in patients with hepatic insufficiency and in healthy individuals. STABLON can therefore be prescribed even in the presence of hepatocellular insufficiency or cirrhosis, at the usual dose of three tablets per day.^5,6

References:

STABLON's acceptability profile is very good, and in practice side effects are rare and generally mild to moderate.

STABLON is free of the expected adverse effects of its therapeutic group.^1-3 STABLON is neither a sedative nor a stimulant. It has no anticholinergic actions. It does not modify hemodynamic parameters, nor cardiac performance. STABLON does not cause weight gain, does not influence the regulation of hormonal secretions and has no statistically significant influence on laboratory parameters.^4,5 A study conducted in patients presenting with a major depressive state or bipolar depressive disorder^6,7 showed that the acceptability of STABLON was greater than that of imipramine. On the other hand, a retrospective survey confirms that STABLON does not induce any sexual dysfunction neither libido trouble.⁸

The excellent acceptability of STABLON is confirmed in the long term and enables prolonged treatment. A study conducted over 16 ½ months of treatment in the prevention of relapse and recurrence showed not only that STABLON prevents relapse and recurrence of depression, but that its excellent acceptability is maintained long term.⁹

This good acceptability reflects the selectivity of action of STABLON and its complete action on depression. Both of these factors⁵ are also reflected in individuals particularly prone to rapidly abandon prescribed treatment such as depressed alcoholics¹⁰ or the elderly depressed^11.

References:

Yes, the hepatic safety/acceptability of STABLON is good.

STABLON brought about no statistically significant change in liver function tests in clinical trials, even in patients treated for prolonged periods.^1,2 These results have been confirmed in depressed alcoholics during withdrawal^1,3 as well as in the elderly.⁴

Pharmacokinetic parameters which characterize the distribution and elimination of tianeptine are statistically similar in hepatic insufficiency patients and in healthy individuals.⁵

Tianeptine and its main metabolite MC5 are essentially eliminated by b-oxidation, a relatively infrequent route for drugs. A metabolic in vitro study with human hepatocytes has shown that this metabolic pathway predominated and persisted when P450 was inhibited, demonstrating that there is no pharmacokinetic interaction between tianeptine and drugs whose metabolism depends on P450.⁶

From a practical standpoint, it is not necessary to modify the usual dose of STABLON of 37.5 mg per day, even in the presence of hepatocellular insufficiency, hepatic cirrhosis, or in case of coprescription of a drug metabolized by the liver.

References:

Unlike other antidepressants, including serotonin reuptake inhibitors,¹ STABLON has no deleterious effect on libido.

The trend in the scores on a specific and internationally validated rating scale shows a statistically significant and marked improvement in sexual dysfunction. These results have been confirmed by long-term studies.^2-5

In addition, a meta-analysis of 231 patients has just been published.⁶ Analysis of the trend in specific libido scores showed that improvement in libido in the STABLON group was 2.15 times better than in the placebo group, and that this improvement was statistically significant (p=0.002), thus confirming that, STABLON does not have a deleterious effect on libido.

References:

References:

1. Sonawalla S, Chakraborty N, Parikh R. Treatment of major depression and anxiety with the selective serotonin reuptake enhancer tianeptine in the outpatient psychiatric care setting of India. Journal of Indian Medical Association 2003; 101(2): 116-117.