Agomelatine in Depressed Patients With Fibromyalgia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01731899

Enrollment

Registered

2012-11-22

Start date

2010-06-30

Completion date

2012-11-30

Last updated

2014-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression, Fibromyalgia

Keywords

major depression, fibromyalgia, agomelatine, Becks' Depression Inventory (BDI), Pittsburgh's Sleep Quality Index (PSQI)

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

Interventions

DRUGagomelatine

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
change, from baseline to endpoint, in the Beck's depression inventory score	12 weeks

Secondary

Measure	Time frame
change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory	12 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026