Agomelatine in Depressed Patients With Fibromyalgia

Sponsor

Universidad de Granada (Other)

Overall Status

Completed

CT.gov ID

NCT01731899

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depression Fibromyalgia	Drug: agomelatine

Detailed 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

Study Design

Study Type:

Observational

Actual Enrollment :

27 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

agomelatine

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

Drug: agomelatine

Agomelatine 25 mg pills. Initial dose 25 mg at bedtime; can be increased up to 50 mg at bedtime; 12 weeks duration

Other Names:

Valdoxan

Outcome Measures

Primary Outcome Measures

change, from baseline to endpoint, in the Beck's depression inventory score [12 weeks]

Secondary Outcome Measures

change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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