Clinical trial NCT01731899: Agomelatine in Depressed Patients With Fibromyalgia
Official title: Observational Study Evaluating the Efficacy and Tolerability of Agomelatine in the Treatment of Depressed Patients With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depression
Fibromyalgia
Keywords: major depression
fibromyalgia
agomelatine
Becks' Depression Inventory (BDI)
Pittsburgh's Sleep Quality Index (PSQI)
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients suffering fibromyalgia and concomitant major depression

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

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

Primary outcomes:
measure: change, from baseline to endpoint, in the Beck's depression inventory score
timeFrame: 12 weeks
Secondary outcomes:
measure: change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Instituto de Neurociencias
Study officials:
affiliation: Universidad de Granada
name: Elena P Calandre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.