Observational Study to Assess a 6-months Treatment With Gladem

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

• Evaluation of a 6-months treatment with Gladem

• Experiences with the internet for performing a postmarketing study (PMS) trial

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Sertraline

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.