Agomelatine in Depressed Patients With Fibromyalgia

Completed

• Conditions: Major Depression; Fibromyalgia
• Interventions: Drug: agomelatine

• Registration Number: NCT01731899
• Lead Sponsor: Universidad de Granada

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.

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 Timeline

• Study Start: 2010-06
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Study First Submitted: 2012-11-17
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-22
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-06
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
change, from baseline to endpoint, in the Beck's depression inventory score	12 weeks

Secondary Outcome Measures

Name	Time	Method
change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory	12 weeks

Trial Locations

Locations (1)

Instituto de Neurociencias; 🇪🇸 Granada, Spain