Observational Study to Assess a 6-months Treatment With Gladem

An observational study of Depressive Disorder, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Depressive Disorder
What is being tested?: Gladem
How many people: 546 participants
Where: No sites listed yet
Study dates: Sep 2000to Jan 2003
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: out-patients

Who may be able to join

Men and women at least 18 years old
De novo prescription of Gladem
Treatment with Gladem intended for at least 6 months
Depressive disorders

Who cannot join

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

Show all 10Show fewer

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.

About this study

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

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

Conditions: Depressive Disorder
Being tested: Gladem
Medical subject headings: Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GlademDrug

Study groups in NCT02231268
Study group	Role	What they receive
Depressive patients		Not described Receives: Drug: Gladem

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hamilton Depression Scale (HAMD-6)
Measured: 3 months, 6 months

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2000Jan 2003

First posted4 Sep 2014 (estimated)
Study startSep 2000
Primary completionJan 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 546 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02231268
Sponsor's protocol ID: 533.2
Status last verified: Aug 2014
First submitted: 2 Sep 2014
Last updated: 4 Sep 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
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Trial Phase: Syndemic Adapted Medly Uganda
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Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
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All Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study Via Internet to Assess a 6-months Treatment With GLADEM
ClinicalTrials.gov ID: NCT02231268
Acronym / sponsor ID: 533.2
Conditions: Depressive Disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 546 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2000
Primary completion: Jan 2003 (actual)
First posted: 4 Sep 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Depressive patients	–	Drug: Gladem

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: out-patients

Key inclusion criteria (4 listed)

Men and women at least 18 years old
De novo prescription of Gladem
Treatment with Gladem intended for at least 6 months
Depressive disorders

Key exclusion criteria (10 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gladem	Drug	Depressive patients

Primary outcome

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

7 secondary outcomes

Global assessment of efficacy on a 4-point scale
Time frame: up to 6 months
Global assessment of compliance on a 4-point scale
Time frame: up to 6 months
Global assessment of tolerability on a 4-point scale
Time frame: up to 6 months
Clinical global impression score
Time frame: up to 6 months
Number of responders
Time frame: up to 6 months
Change in HAMD subscores
Time frame: baseline, 6 months
Number of patients with adverse drug reactions
Time frame: up to 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.

Related trials for Depressive Disorder

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Depressive Disorder, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hamilton Depression Scale (HAMD-6) (time frame: 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02231268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2014.