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Off-label use of psychotropic medications: focus on antidepressants. Donatella Marazziti Dipartimento di Psichiatria, Neurobiologia, Farmacologia e Biotecnologie Università di Pisa. Current Antidepressants. TCA IMAO SSRI NARI NASSA SNRI. Approved Uses of Antidepressants.
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focus on antidepressants
Dipartimento di Psichiatria, Neurobiologia,
Farmacologia e Biotecnologie
Università di Pisa
Unfavorable side effect profile
Several studies about prophylaxis use of SSRI
Adly et al., 1992; Saper et al., 1994; Steiner et al., 1998; D’Amato et al., 1999
A comparative study of amitriptyline and fluvoxamine in migraine prophylaxis
- Amitriptyline significantly reduced the number of headache attacks, but caused severe drowsiness in many patients.
- Fluvoxamine influenced positively the number of headache attacks and caused only slight side effects.
Tension-type headaches (TTH): comparison between SSRIs and other antidepressants
paroxetine vs sulpiride
fluvoxamine vs mianserine
citalopram vs amitriptyline
fluoxetine vs desimipramine
fluoxetine vs amitriptyline
sertraline vs amitriptyline
No significant differences; both effective to reduce headache severity
Both medications reduced the number of days with TTH
Amitriptyline reduced headache duration
No significant differences in change of pain score from baseline to three months
In chronic TTH amitriptyline reduced headache frequency both at 8 and 12 weeks while fluoxetine only at 8 weeks; the situation was reversed in episodic TTH
> 50% reduction in headache
In patients with chronic TTH, SSRIs are less effictive than tricyclics which, in turn, produce more severe adverse events.
Moja et al., 2005
Other medications, such as venlafaxine, are effective in other pain conditions, but have not been rigorously studied in headache.
Loder et al., 2004
It is the involuntary loss of urine associated with physical activities such as running, jumping, or lifting, or with sneezing and coughing.
For many patients it can be a bothersome symptom, causing social isolation, loss of self-esteem, and increased expenses.
Although there is currently no single medication approved worldwide for the treatment of SUI, a variety of off-label agents are often prescribed.
Treatment with Imipramine (50 mg/day) was associated with clinical improvement in 72% of 22 women with SUI.
Woodman et al 2001
Duloxetine is believed to increase the strength of urethral sphincter contractions and, thereby, prevent accidental urine leakage by increasing urethral closure forces.
In clinical trials in women with SUI, duloxetine has demonstrated efficacy in reducing incontinence episodes and increasing the quality of life with no serious adverse effects.
Zinner et al., 2004
They are well established as effective treatment of the symptoms of diabetic neuropathy
Carbamazepine and gabapentin are other drugs shown to be effective in treating neuropathic pain
SSRIs (in particular paroxetine) should not be considered as first-line therapy for Diabetic Neuropathy, because the evidence for their use for this purpose is limited
Disturbances in biogenic amines are documented in patients with Fibromyalgia
Agents interacting with these systems have been tested extensively
There are no treatments for fibromyalgia currently approved by the FDA or the European Agency
The most used
Significant effects in
Turk at al, 2002
The most common aused
The combination of Fluoxetine and Amitriptyline was shown to be more efficactive in FM than either agent alone or placebo, possibly indicating a weak analgesic effect of SSRIs in the presence of a TCA
SSRIs associated or not with TCAs can be considered as an alternative tool in patients with partial response to non-pharmacological therapies
Arnold LM et al, 2003;Sayar K et al, 2003
Neurocardiogenic syncope is a common disorder of transient autonomic nervous system dysfunction
No definitive treatment is available
Calkins et al., 1999
20 mg daily was found to significantly improve symptoms in patients refractory or intolerant to standard treatments (atenolol, midodrine, fluorocortisol)
Showed promising results; most patients remained symptom-free for at least six months
Di Girolamo et al, 1999 1; Grubb et al, 1994 2; Lenk et al, 1997
Only paroxetine has been recently
approved by the FDA for GAD treatment
Kent et al, 1998 1; Wylie et al, 2000 2
Since mid-1980s there has been a rapid increase in the off-label use of antidepressants, particularly trazodone, for treating insomnia.
Mendelson et al., 2004
The primary FDA approved non-nicotine pharmacotherapy agent is bupropion...
...but studies summarize the effectiveness of other off-label medications, such as
• Tricyclic antidepressants
• SSRIs (Fluvoxamine)
Dudas and George, 2005
1st Cardiovascular agents
2nd Psychotropic agents
3rd Antiallergic agents
Doctors pour drugs of which they know little, to cure diseases of which they know less, into human beings of whom they know nothing.