Major DepressionNCT01731899
Agomelatine in Depressed Patients With Fibromyalgia
An observational study of Major Depression and Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depression, Fibromyalgia
- What is being tested?
- agomelatine
- Type of treatment
- Pill or oral medicine
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2010to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients suffering fibromyalgia and concomitant major depression
Who may be able to join
- 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
Who cannot join
- other psychiastric concomitant illness
- pregnancy or lactation
- patients previously treated with agomelatine with little or no effect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study Evaluating the Efficacy and Tolerability of Agomelatine in the Treatment of Depressed Patients With Fibromyalgia
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.
Read the 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
- Conditions
- Major Depression, Fibromyalgia
- Being tested
- agomelatine
- Keywords
- major depression, fibromyalgia, agomelatine, Becks' Depression Inventory (BDI), Pittsburgh's Sleep Quality Index (PSQI)
- Medical subject headings
- Depressive Disorder, Major, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
agomelatineDrug
Also called Valdoxan
Agomelatine 25 mg pills. Initial dose 25 mg at bedtime; can be increased up to 50 mg at bedtime; 12 weeks duration
| Study group | Role | What they receive |
|---|---|---|
| agomelatine | patients diagnosed of fibromyalgia and concomitant major depression receiving agomelatine for this later disease Receives: Drug: agomelatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change, from baseline to endpoint, in the Beck's depression inventory score
Measured: 12 weeks
Secondary outcomes (1)
change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startJun 2010
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Pita Calandre, Universidad de Granada
- Investigators
- Elena P Calandre, MD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731899
- Sponsor's protocol ID
- AGO-2010
- Status last verified
- May 2014
- First submitted
- 17 Nov 2012
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24549860
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the Efficacy and Tolerability of Agomelatine in the Treatment of Depressed Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01731899
- Acronym / sponsor ID
- AGO-2010
- Conditions
- Major Depression, Fibromyalgia
- Keywords
- major depression, fibromyalgia, agomelatine, Becks' Depression Inventory (BDI), Pittsburgh's Sleep Quality Index (PSQI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| agomelatine | – | Drug: agomelatinepatients diagnosed of fibromyalgia and concomitant major depression receiving agomelatine for this later disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffering fibromyalgia and concomitant major depression
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- other psychiastric concomitant illness
- pregnancy or lactation
- patients previously treated with agomelatine with little or no effect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| agomelatineAlso: ValdoxanAgomelatine 25 mg pills. Initial dose 25 mg at bedtime; can be increased up to 50 mg at bedtime; 12 weeks duration | Drug | agomelatine |
Primary outcome
change, from baseline to endpoint, in the Beck's depression inventory score
Time frame: 12 weeks
1 secondary outcome
change, from baseline to endpoint, in the Pittsburgh Sleep Quality Inventory
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Results publication: PubMed 24549860Calandre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena P Calandre, MD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression and Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change, from baseline to endpoint, in the Beck's depression inventory score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01731899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.