Status:
COMPLETED
Observational Study to Assess a 6-months Treatment With Gladem
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Depressive Disorder
Eligibility:
All Genders
18+ years
Brief Summary
* Evaluation of a 6-months treatment with Gladem * Experiences with the internet for performing a postmarketing study (PMS) trial
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT02231268
Start Date
September 1 2000
Last Update
September 4 2014
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