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Completed

NCT Number: NCT01731899

Agomelatine in Depressed Patients With Fibromyalgia

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.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Fibromyalgia Mental Disorders Mood Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto de Neurociencias

Granada, 18012, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Agomelatine

Drug

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

Primary outcomes

  1. change, from baseline to endpoint, in the Beck's depression inventory score

    Time frame: 12 weeks

Secondary outcomes

  1. change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2012
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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