Agomelatine in Depressed Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731899
• Other study ID #: AGO-2010
• Status: Completed
• Phase: N/A
• First received: November 17, 2012
• Last updated: May 6, 2014
• Start date: June 2010
• Est. completion date: November 2012

Study information

• Verified date: May 2014
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• Fibromyalgia
• Major Depression
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Spain	Instituto de Neurociencias	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Calandre EP, Slim M, Garcia-Leiva JM, Rodriguez-Lopez CM, Torres P, Rico-Villademoros F. Agomelatine for the treatment of patients with fibromyalgia and depressive symptomatology: an uncontrolled, 12-week, pilot study. Pharmacopsychiatry. 2014 Mar;47(2):6 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change, from baseline to endpoint, in the Beck's depression inventory score		12 weeks	No
Secondary	change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory		12 weeks	No