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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT00253266
Eligibility Criteria:
Inclusion Criteria:
* Female and male inpatients with a major depressive disorder without psychotic features or with a depressive episode within a bipolar I or II disorder without psychotic features
* Ages between 20 and 70 years
* Total score greater than 18 on the Hamilton Depression Rating Scale
* Documentation of at least one ineffective antidepressant drug trial under adequate dosage for at least 6 weeks in the current episode
Exclusion Criteria:
* Other psychiatric axis I disorders than those mentioned as Inclusion criteria
* Acute suicidality (Item 3 of the Hamilton Depression Rating Scale greater than 2)
* Drug or alcohol addiction
* Patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
* Documentation or report of a previous ineffective treatment trial with venlafaxine, lamotrigine or quetiapine
* Functional kidney disorders
* Untreated hypertension
* Acute treatment with thyroid hormone (less than 3 months)
* Pregnant or nursing patients
* Women of childbearing age without effective contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT00253266
Study Brief:
Protocol Section:
NCT00253266