Agomelatine in Depressed Patients With Fibromyalgia
Observational Study Evaluating the Efficacy and Tolerability of Agomelatine in the Treatment of Depressed Patients With Fibromyalgia
1 other identifier
observational
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 17, 2012
CompletedFirst Posted
Study publicly available on registry
November 22, 2012
CompletedMay 7, 2014
May 1, 2014
2.3 years
November 17, 2012
May 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change, from baseline to endpoint, in the Beck's depression inventory score
12 weeks
Secondary Outcomes (1)
change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory
12 weeks
Study Arms (1)
agomelatine
patients diagnosed of fibromyalgia and concomitant major depression receiving agomelatine for this later disease
Interventions
Agomelatine 25 mg pills. Initial dose 25 mg at bedtime; can be increased up to 50 mg at bedtime; 12 weeks duration
Eligibility Criteria
Adult patients suffering fibromyalgia and concomitant major depression
You may qualify if:
- 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
You may not qualify if:
- other psychiastric concomitant illness
- pregnancy or lactation
- patients previously treated with agomelatine with little or no effect
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Neurociencias
Granada, Granada, 18012, Spain
Related Publications (1)
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.
PMID: 24549860RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena P Calandre, MD
Universidad de Granada
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 17, 2012
First Posted
November 22, 2012
Study Start
June 1, 2010
Primary Completion
October 1, 2012
Study Completion
November 1, 2012
Last Updated
May 7, 2014
Record last verified: 2014-05