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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT02231268
Eligibility Criteria:
Inclusion Criteria:
* Men and women at least 18 years old
* De novo prescription of Gladem
* Treatment with Gladem intended for at least 6 months
* Depressive disorders
Exclusion Criteria:
* Known hypersensitivity against sertraline
* Concomitant treatment with monoamine oxidase (MAO)-inhibitors, selegiline, moclobemide (washout for at least 14 days necessary)
* Concomitant treatment with other serotoninergic substances like tryptophan or fenfluramine
* Instable epilepsy
According to product information (October 1998) Gladem prescription was possible with precautions in the following cases:
* Patients with stable epilepsy
* Patients with restricted liver functions
* Suicidal patients
* Patients in emotional state and marked sleeping disorders
According to product information (October 1998) Gladem should only be prescribed during pregnancy and lactation period, if the expected benefit was greater than the risk. Women of childbearing age should use Gladem only in combination with sufficient contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02231268
Study Brief:
Protocol Section:
NCT02231268