Agomelatine in Depressed Patients With Fibromyalgia | NCT01731899

Studies
Agomelatine in Depressed Patients With Fibromyalgia

NCT01731899

Sponsor

Universidad de Granada

Status

Completed

Last Update Posted

May 7, 2014Estimated

Enrollment

27Actual

Phase

Not provided

Conditions

Major Depression
Fibromyalgia

Interventions

agomelatine

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Oct 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Nov 17, 2012

First Submission Date that Met QC Criteria

Nov 21, 2012

First Posted Date

Nov 22, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2014

Last Update Posted Date

May 7, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
agomelatine		patients diagnosed of fibromyalgia and concomitant major depression receiving agomelatine for this later disease	Drug: agomelatine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
agomelatine	Drug	Agomelatine 25 mg pills. Initial dose 25 mg at bedtime; can be increased up to 50 mg at bedtime; 12 weeks duration	agomelatine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients suffering fibromyalgia and concomitant major depression

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elena P Calandre, MD	Universidad de Granada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Neurociencias		Granada	Granada	18012	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24549860	Result	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.

ID	Term
D003865	Depressive Disorder, Major
D005356	Fibromyalgia

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D009135	Muscular Diseases