Agomelatine in Depressed Patients With Fibromyalgia

University of Granada (UGR)

Status: Completed

Conditions: Fibromyalgia; Major Depression

Treatments: Drug: agomelatine

Study type: Observational

Funder types: Other

Identifiers

NCT01731899

AGO-2010

Details and patient eligibility

About

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.

Full description

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

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

27 participants in 1 patient group

agomelatine

Description:

patients diagnosed of fibromyalgia and concomitant major depression receiving agomelatine for this later disease

Treatment:

Drug: agomelatine