Observational Study to Assess a 6-months Treatment With G... | NCT02231268

Studies
Observational Study to Assess a 6-months Treatment With Gladem

NCT02231268

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 4, 2014Estimated

Enrollment

546Actual

Phase

Not provided

Conditions

Depressive Disorder

Interventions

Gladem

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2000

Primary Completion Date

Jan 2003Actual

Completion Date

Not provided

First Submitted Date

Sep 2, 2014

First Submission Date that Met QC Criteria

Sep 2, 2014

First Posted Date

Sep 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2014

Last Update Posted Date

Sep 4, 2014Estimated

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

546Actual

Label	Type	Description	Intervention Names
Depressive patients			Drug: Gladem

Name	Type	Description	Arm Group Labels	Other Names
Gladem	Drug		Depressive patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Global assessment of efficacy on a 4-point scale		up to 6 months
Global assessment of compliance on a 4-point scale		up to 6 months
Global assessment of tolerability on a 4-point scale

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

out-patients

Sampling Method

Not provided

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D015057	1-Naphthylamine
D000588	Amines
D009930	Organic Chemicals
D009281	Naphthalenes