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Agomelatine in Depressed Patients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01731899
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : May 7, 2014
Sponsor:
Information provided by (Responsible Party):

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
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 : June 2010
Primary Completion Date : October 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort 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 Name: Valdoxan


Outcome Measures

Primary Outcome Measures :
  1. change, from baseline to endpoint, in the Beck's depression inventory score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients suffering fibromyalgia and concomitant major depression
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731899


Locations
Spain
Instituto de Neurociencias
Granada, Spain, 18012
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Elena P Calandre, MD Universidad de Granada
More Information

Publications:
Responsible Party: Elena Pita Calandre, Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01731899     History of Changes
Other Study ID Numbers: AGO-2010
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014

Keywords provided by Elena Pita Calandre, Universidad de Granada:
major depression
fibromyalgia
agomelatine
Becks' Depression Inventory (BDI)
Pittsburgh's Sleep Quality Index (PSQI)

Additional relevant MeSH terms:
Depression
Fibromyalgia
Myofascial Pain Syndromes
Depressive Disorder, Major
Behavioral Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Depressive Disorder
Mood Disorders
Mental Disorders
S 20098
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs