Observational Study to Assess a 6-months Treatment With Gladem

Observational Study Via Internet to Assess a 6-months Treatment With GLADEM

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02231268

Enrollment

546

Registered

2014-09-04

Start date

2000-09-30

Completion date

Unknown

Last updated

2014-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

Brief summary

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

Interventions

DRUGGladem

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Change in Hamilton Depression Scale (HAMD-6)	3 months, 6 months

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026