Agomelatine in Depressed Patients With Fibromyalgia

NCT ID: NCT01731899

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-11-30

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

Conditions

Major Depression; Fibromyalgia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

agomelatine

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

agomelatine

Intervention Type: DRUG

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

Interventions

agomelatine

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

Intervention Type: DRUG

Other Intervention Names

Valdoxan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Elena Pita Calandre

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena P Calandre, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Instituto de Neurociencias

Granada, Granada, Spain

Countries

Spain

References

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):67-72. doi: 10.1055/s-0033-1363659. Epub 2014 Feb 18.

Reference Type: RESULT

PMID: 24549860 (View on PubMed)

Other Identifiers

AGO-2010

Identifier Type: -

Identifier Source: org_study_id