Observational Study to Assess a 6-months Treatment With Gladem

Completed

• Conditions: Depressive Disorder
• Interventions: Drug: Gladem

• Registration Number: NCT02231268
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

* Evaluation of a 6-months treatment with Gladem

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2003-01
• Status Verified: 2014-08
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-02
• Last Update Submitted: 2014-09-02
• Study First Posted: 2014-09-04
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 546

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Depressive patients	Gladem	-

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Scale (HAMD-6)	3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
Global assessment of tolerability on a 4-point scale	up to 6 months
Number of responders	up to 6 months	\>= 50 % reduction in HAMD-6 score
Change in HAMD subscores	baseline, 6 months
Global assessment of compliance on a 4-point scale	up to 6 months
Global assessment of efficacy on a 4-point scale	up to 6 months
Clinical global impression score	up to 6 months
Number of patients with adverse drug reactions	up to 6 months