Agomelatine in Depressed Patients With Fibromyalgia

Study Overview
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Brief Summary
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Depression and unrefreshed sleep are frequent in patients with fibromyalgia. Agomelatine is a new antidepressant with sleep-promoting properties. The objective of this study include the assessment of agomelatine therapy in patients with depression and fibromyalgia both on the severity of depressive symptomatology and sleep quality.

Detailed Description
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One of the most frequent comorbidities of fibromyalgia is major depression. Agomelatine is a new antidepressant whose mechanims of action include both agonism at melatonin receptores and 5-HT2C blocking properties which, in addition to antidepressant efficacy, has shown sleep-improving properties. As unrefreshed sleep is a common symptom in fibromyalgia we hypothetized that agomelatine treatment of patients with concomitant depression and fibromyalgia could improve both depressive symtomatology and sleep quality. Thus, the objectives of the present study are the following: to assess the effectiveness and tolerability of agomelatine on the severity of depressive symptomatology in patients with fibromyalgia and concomitatnt depresssion to evaluate the effect of agomelatine treatment on sleep quality in these patients

Official Title
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Observational Study Evaluating the Efficacy and Tolerability of Agomelatine in the Treatment of Depressed Patients With Fibromyalgia

Conditions
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Major Depression, Fibromyalgia

Intervention / Treatment
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* Drug: agomelatine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria diagnosed of major depression according to the DSM-IV criteria with a BDI-II score equal or higher tahn 20 Exclusion Criteria: other psychiastric concomitant illness pregnancy or lactation patients previously treated with agomelatine with little or no effect

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| agomelatine<br>patients diagnosed of fibromyalgia and concomitant major depression receiving agomelatine for this later disease | Drug: agomelatine<br>* Agomelatine 25 mg pills. Initial dose 25 mg at bedtime; can be increased up to 50 mg at bedtime; 12 weeks duration<br>* Other names: Valdoxan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change, from baseline to endpoint, in the Beck's depression inventory score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major depression, fibromyalgia, agomelatine, Becks' Depression Inventory (BDI), Pittsburgh's Sleep Quality Index (PSQI)