Observational Study to Assess a 6-months Treatment With Gladem

Boehringer Ingelheim

Status: Completed

Conditions: Depressive Disorder

Treatments: Drug: Gladem

Study type: Observational

Funder types: Industry

Identifiers

NCT02231268

533.2

Details and patient eligibility

About

• Evaluation of a 6-months treatment with Gladem
• Experiences with the internet for performing a postmarketing study (PMS) trial

Enrollment: 546 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

546 participants in 1 patient group

Depressive patients

Treatment:

Drug: Gladem