Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT00531895
Eligibility Criteria:
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00531895
Study Brief:
Protocol Section:
NCT00531895