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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT00398632
Eligibility Criteria:
Inclusion Criteria::
* age 18 - 65 inclusive
* able to read and understand informed consent
* informed consent given
* currently being treated with an SSRI for depression or dysthymia
* currently suffering from treatment-emergent sexual dysfunction attributable to the SSRI
* have normal safety lab values at screen
* if currently taking medication to improve sexual performance, willing to discontinue the drug for the duration of the study
* female subjects of child bearing age need to use an acceptable form of birth control throughout the study Exclusion Criteria:- being pregnant, breastfeeding, or planning to become pregnant within 4 months
* suffering from psychotic, substance abuse, bipolar, or organic mental disorder, OCD, panic disorder, or personality disorder severe enough to interfere with study participation
* suffer from an unstable or serious medical disorder
* having a medical disorder that could be the cause of the sexual dysfunction
* taking a medication that is metabolized by hepatic enzyme CYP2D6
* having used a MAOI within 15 days of proposed start of duloxetine treatment
* having a known hypersensitivity to duloxetine or any of its ingredients
* having taken viagra or related drug within 3 months prior to starting SSRI treatment
* requiring ongoing treatment with a mood stabilizer (anticonvulsant) or antipsychotic medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00398632
Study Brief:
Protocol Section:
NCT00398632