Major DepressionPhase 4NCT00531895
An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
A Phase 4 study testing duloxetine in people with Major Depression and Chronic Primary Headache, run by Kraepelin Psiquiatria Clinica at 1 site in Brazil.
Trial summary
Background: Although major depression and chronic headache are strongly associated, there is insufficient evidence on the use of antidepressants for this specific comorbidity. This trial aimed to investigate the efficiency and tolerability of duloxetine for this indication. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depression, Chronic Primary Headache
- What is being tested?
- duloxetine
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2006to Mar 2007
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major depression (according to DSM-IV criteria)
- MADRS scores superior to 21
- Subjects meeting the International Headache Society criteria for chronic primary headache (IHSC-2 codes 1.5.1, 1.6.1, 2.3.1, 2.3.2 and 2.4.3) (ICHS, 2003)
Who cannot join
- Over 50% reduction on MADRS scores during wash-out period
- Illicit drug or alcohol dependence
- History of multiple allergies or hypersensitivity to duloxetine
- History of epilepsy or significant neurological disorder
- Significant suicide risk
- Pregnancy or lactation
Show all 10Show fewer
- Sexually active female subjects not using an efficient contraceptive method
- Significant laboratory abnormalities at baseline
- Significant clinical disease
- Subjects meeting DSM-IV criteria for somatisation disorder. (300.81) or presenting with delusional pain symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Although major depression and chronic headache are strongly associated, there is insufficient evidence on the use of antidepressants for this specific comorbidity. This trial aimed to investigate the efficiency and tolerability of duloxetine for this indication.
Methods: Thirty outpatients of our clinic, with DSM-IV major depression and concurrent primary chronic headache (chronic migraine, chronic tension-type headache or both), 18-55 years, were recruited from April 2006 to March 2007, if they scored >21 on the Montgomery-Äsberg Depression Scale (MADRS) and had no other significant clinical condition. Subjects received duloxetine 60 mg/day for 8 weeks. MADRS scores and a visual analog pain scale (VAS) were the co-primary outcome measures. WHO quality of life scale (WHOQoL BREF) scores and headache days/week were secondary outcome measures.Conclusion: In this preliminary open trial, duloxetine 60 mg/day was effective, fast acting and well tolerated for the treatment of comorbid major depression and chronic headache.
- Conditions
- Major Depression, Chronic Primary Headache
- Being tested
- duloxetine
- Keywords
- major depression, chronic headache, antidepressant, duloxetine
- Medical subject headings
- Depressive Disorder, Major, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
Also called Cymbalta
duloxetine 60 mg/d
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Äsberg Depression Scale (MADRS)
Measured: 8 weeks
Visual Analog Scale for pain (VAS)
Measured: 8 weeks
Secondary outcomes (1)
WHO Quality of Life Scale (WHOQOL BREF)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startApr 2006
- Study completionMar 2007
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kraepelin Psiquiatria Clinica
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Fernando M Volpe, MD, PhD, Principal investigator, Hospital SOCOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531895
- Sponsor's protocol ID
- O021
- Status last verified
- Aug 2007
- First submitted
- 18 Sep 2007
- Last updated
- 19 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Volpe FM. An 8-week, open-label trial of duloxetine for comorbid major depressive disorder and chronic headache. J Clin Psychiatry. 2008 Sep;69(9):1449-54. doi: 10.4088/jcp.v69n0912.
PubMed 19193344
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
- ClinicalTrials.gov ID
- NCT00531895
- Acronym / sponsor ID
- O021
- Conditions
- Major Depression, Chronic Primary Headache
- Keywords
- major depression, chronic headache, antidepressant, duloxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kraepelin Psiquiatria ClinicaUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Apr 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 19 Sep 2007 (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.
Background: Although major depression and chronic headache are strongly associated, there is insufficient evidence on the use of antidepressants for this specific comorbidity. This trial aimed to investigate the efficiency and tolerability of duloxetine for this indication.
Methods: Thirty outpatients of our clinic, with DSM-IV major depression and concurrent primary chronic headache (chronic migraine, chronic tension-type headache or both), 18-55 years, were recruited from April 2006 to March 2007, if they scored >21 on the Montgomery-Äsberg Depression Scale (MADRS) and had no other significant clinical condition. Subjects received duloxetine 60 mg/day for 8 weeks. MADRS scores and a visual analog pain scale (VAS) were the co-primary outcome measures. WHO quality of life scale (WHOQoL BREF) scores and headache days/week were secondary outcome measures.Conclusion: In this preliminary open trial, duloxetine 60 mg/day was effective, fast acting and well tolerated for the treatment of comorbid major depression and chronic headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Major depression (according to DSM-IV criteria)
- MADRS scores superior to 21
- Subjects meeting the International Headache Society criteria for chronic primary headache (IHSC-2 codes 1.5.1, 1.6.1, 2.3.1, 2.3.2 and 2.4.3) (ICHS, 2003)
Key exclusion criteria (10 listed)
- Over 50% reduction on MADRS scores during wash-out period
- Illicit drug or alcohol dependence
- History of multiple allergies or hypersensitivity to duloxetine
- History of epilepsy or significant neurological disorder
- Significant suicide risk
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 |
|---|---|---|
| duloxetineAlso: Cymbaltaduloxetine 60 mg/d | Drug | – |
Primary outcome
Montgomery-Äsberg Depression Scale (MADRS)
Time frame: 8 weeks
Visual Analog Scale for pain (VAS)
Time frame: 8 weeks
1 secondary outcome
WHO Quality of Life Scale (WHOQOL BREF)
Time frame: 8 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 19 Sep 2007.
- Derived from this study: PubMed 19193344Volpe FM. An 8-week, open-label trial of duloxetine for comorbid major depressive disorder and chronic headache. J Clin Psychiatry. 2008 Sep;69(9):1449-54. doi: 10.4088/jcp.v69n0912.
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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.
Fernando M Volpe, MD, PhD principal investigator
Hospital SOCOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing duloxetine in people with Major Depression and Chronic Primary Headache, run by Kraepelin Psiquiatria Clinica at 1 site in Brazil.
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 10 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 19 Sep 2007. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Montgomery-Äsberg Depression Scale (MADRS) (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT00531895, 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 19 Sep 2007.