Observational Study to Assess a 6-months Treatment With Gladem

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231268
• Other study ID #: 533.2
• Status: Completed
• Phase: N/A
• First received: September 2, 2014
• Last updated: September 2, 2014
• Start date: September 2000

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

• Evaluation of a 6-months treatment with Gladem

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Gladem

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Scale (HAMD-6)		3 months, 6 months	No
Secondary	Global assessment of efficacy on a 4-point scale		up to 6 months	No
Secondary	Global assessment of compliance on a 4-point scale		up to 6 months	No
Secondary	Global assessment of tolerability on a 4-point scale		up to 6 months	No
Secondary	Clinical global impression score		up to 6 months	No
Secondary	Number of responders	>= 50 % reduction in HAMD-6 score	up to 6 months	No
Secondary	Change in HAMD subscores		baseline, 6 months	No
Secondary	Number of patients with adverse drug reactions		up to 6 months	No

External Links

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