Agomelatine in Depressed Patients With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elena Pita Calandre, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01731899
First received: November 17, 2012
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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 Intervention
Major Depression
Fibromyalgia
Drug: agomelatine

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • change, from baseline to endpoint, in the Beck's depression inventory score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Elena Pita Calandre, Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01731899     History of Changes
Other Study ID Numbers: AGO-2010
Study First Received: November 17, 2012
Last Updated: November 21, 2012
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on April 17, 2014