<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01731899</url>
  </required_header>
  <id_info>
    <org_study_id>AGO-2010</org_study_id>
    <nct_id>NCT01731899</nct_id>
  </id_info>
  <brief_title>Agomelatine in Depressed Patients With Fibromyalgia</brief_title>
  <official_title>Observational Study Evaluating the Efficacy and Tolerability of Agomelatine in the Treatment of Depressed Patients With Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Granada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depression and unrefreshed sleep are frequent in patients with fibromyalgia. Agomelatine is a&#xD;
      new antidepressant with sleep-promoting properties. The objective of this study include the&#xD;
      assessment of agomelatine therapy in patients with depression and fibromyalgia both on the&#xD;
      severity of depressive symptomatology and sleep quality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the most frequent comorbidities of fibromyalgia is major depression. Agomelatine is a&#xD;
      new antidepressant whose mechanims of action include both agonism at melatonin receptores and&#xD;
      5-HT2C blocking properties which, in addition to antidepressant efficacy, has shown&#xD;
      sleep-improving properties. As unrefreshed sleep is a common symptom in fibromyalgia we&#xD;
      hypothetized that agomelatine treatment of patients with concomitant depression and&#xD;
      fibromyalgia could improve both depressive symtomatology and sleep quality. Thus, the&#xD;
      objectives of the present study are the following:&#xD;
&#xD;
        -  to assess the effectiveness and tolerability of agomelatine on the severity of&#xD;
           depressive symptomatology in patients with fibromyalgia and concomitatnt depresssion&#xD;
&#xD;
        -  to evaluate the effect of agomelatine treatment on sleep quality in these patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change, from baseline to endpoint, in the Beck's depression inventory score</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Major Depression</condition>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>agomelatine</arm_group_label>
    <description>patients diagnosed of fibromyalgia and concomitant major depression receiving agomelatine for this later disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>agomelatine</intervention_name>
    <description>Agomelatine 25 mg pills. Initial dose 25 mg at bedtime; can be increased up to 50 mg at bedtime; 12 weeks duration</description>
    <arm_group_label>agomelatine</arm_group_label>
    <other_name>Valdoxan</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients suffering fibromyalgia and concomitant major depression&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients&#xD;
&#xD;
          -  diagnosed of fibromyalgia according to the American College of Rheumatology criteria&#xD;
&#xD;
          -  diagnosed of major depression according to the DSM-IV criteria with a BDI-II score&#xD;
             equal or higher tahn 20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other psychiastric concomitant illness&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  patients previously treated with agomelatine with little or no effect&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena P Calandre, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Granada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Neurociencias</name>
      <address>
        <city>Granada</city>
        <zip>18012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>24549860</PMID>
  </results_reference>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>November 17, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>May 6, 2014</last_update_submitted>
  <last_update_submitted_qc>May 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Elena Pita Calandre</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>major depression</keyword>
  <keyword>fibromyalgia</keyword>
  <keyword>agomelatine</keyword>
  <keyword>Becks' Depression Inventory (BDI)</keyword>
  <keyword>Pittsburgh's Sleep Quality Index (PSQI)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agomelatine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01731899
org study id: AGO-2010
nct id: NCT01731899
lead sponsor: 
has dmc: No
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.
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
observational model: Cohort
time perspective: Prospective
measure: change, from baseline to endpoint, in the Beck's depression inventory score
time frame: 12 weeks
measure: change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory
time frame: 12 weeks
arm group label: agomelatine
description: patients diagnosed of fibromyalgia and concomitant major depression receiving agomelatine for this later disease
intervention type: Drug
intervention name: agomelatine
description: Agomelatine 25 mg pills. Initial dose 25 mg at bedtime; can be increased up to 50 mg at bedtime; 12 weeks duration
arm group label: agomelatine
other name: Valdoxan
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Elena P Calandre, MD
role: Principal Investigator
affiliation: Universidad de Granada
facility: 
country: Spain
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.
PMID: 24549860
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Elena Pita Calandre
investigator title: Professor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Agomelatine