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 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT00873795
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects 18 to 65 years inclusive.
* Fulfilled DSM-Ⅳ criteria for major depressive disorder.
* Onset ≧2 weeks.
* Baseline score ≧14 on the HAM-D17.
* Written informed consent prior to entry into the study.
Exclusion Criteria:
* HAM-D17 item 3 score≧3.
* Life-time history of bipolar disorders, schizophrenia or schizoaffective disorder.
* Current history of panic disorder, obsessive-compulsive disorder, alcohol or substance abuse.
* Mood disorder due to general medical condition.
* Treatment with antidepressants at entry into the study before 2 weeks.
* Need for psychoactive medications other than the study drugs, except for one benzodiazepine or hypnotic given at a stable dose.
* Known intolerance or inefficacy to either drug.
* Previous lack of response to two or more antidepressants at adequate dosage.
* Subjects who have acute or unstable medical illness or organic failure.
* Pregnancy and breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00873795
Study Brief:
Protocol Section:
NCT00873795