Major Depressive DisorderB2411003NCT00770289

Study Comparing Remission Rates, in Patients With Major Depressive Disorder (MDD)

An observational study of Major Depressive Disorder, run by Pfizer at 3 sites in Greece.

Completed

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

Trial summary

Tools known as 'depression scales 'are widely used as assessments to evaluate a patient's response to treatment. The purpose of this study is the evaluation of the remission rates for patients with MDD. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Cohort
How many people: 851 participants
Where: 3 sitesGreece
Study dates: May 2008to Dec 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients diagnosed with MDD who are either changing treatment or have never received treatment.

Who may be able to join

Outpatients
18-75 years old
Patients diagnosed with MDD according to DSM IV without psychotic symptoms
HAM-D17 > or = 18 on inclusion
Patients receiving treatment for the first time or changing treatment based on their doctor's decision

Who cannot join

Subjects with potentially problematic compliance
Subjects participating in an interventional trial within the last 3 months

Trial locations and contacts

3 sites in 1 country.

Greece3 sites

Pfizer Investigational Site
Haidari, Athens, 12461
Pfizer Investigational Site
Haidari, Athens, 12462
Pfizer Investigational Site
Ilissia, Athens, 11528

Other trials in Greece

About this study

Official title: Open Label, Observational, Non-interventional Study for the Evaluation of Remission Rates in Patients With MDD Under Treatment With Various Anti-depressives

Read the detailed description

12 weeks random

Conditions: Major Depressive Disorder
Being tested: Cohort
Medical subject headings: Depressive Disorder, Major

What participants receive

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

CohortOther
Cohort (Patients diagnosed with MDD who are either changing treatment or have never received treatment).

Study groups in NCT00770289
Study group	Role	What they receive
Single group		Not described Receives: Other: Cohort

What is being measured

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

Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)
Remission according to HAM-D: HAM-D17 score less than or equal to (=<) 7 or a HAM-D7 score =< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.
Measured: Week 12

Secondary outcomes (3)

Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)
Remission according to BDI: BDI score less than (<) 10. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression.
Measured: Week 12
Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)
HAM-D17: clinician-administered scale; assesses 17 items related to major depression (MD). Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: subset of HAM-D17; assesses 7 items related to MD. Total score: 0 to 26. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, physical symptoms of fatigue, weight loss, lack of interest in sex. Individual item scored on 4 point scale (0 to 3); 0=absent, 3=most severe. Total score: 0 to 63. For all the 3 scales, higher score represented more depression.
Measured: Baseline, Week 12
Number of Participants With Residual Symptoms in Case of Non Remission
Number of participants with residual symptoms who did not achieve remission was assessed. Remission according to HAM-D: HAM-D17 score =< 7 or HAM-D7 score =<3. Remission according to BDI: BDI score <10. HAM-D17: assessed 17 items associated with MD. Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: assessed 7 items associated with MD. Total score: 0 to 26. BDI assessed severity of depressive symptoms. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. The total score: 0 to 63. For all the 3 scales, higher score indicated more severe depression.
Measured: Week 12

Timeline

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

May 2008Dec 2009

First posted9 Oct 2008 (estimated)
Study startMay 2008
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by PfizerThe 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
Enrolment: 851 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00770289
Sponsor's protocol ID: 0600B-102374
Other IDs: B2411003
Acronym: B2411003
Status last verified: Aug 2012
First submitted: 8 Oct 2008
Last updated: 31 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label, Observational, Non-interventional Study for the Evaluation of Remission Rates in Patients With MDD Under Treatment With Various Anti-depressives
ClinicalTrials.gov ID: NCT00770289
Acronym / sponsor ID: B2411003 / 0600B-102374
Conditions: Major Depressive Disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 851 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 9 Oct 2008 (estimated)
Results: Posted 31 Aug 2012

Clinical summary

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

Detailed description

12 weeks random

Study design

Observational model: Cohort
Number of arms: 1

Arm	Type	Receives
Single group	–	Other: Cohort

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients diagnosed with MDD who are either changing treatment or have never received treatment.

Key inclusion criteria (5 listed)

Outpatients
18-75 years old
Patients diagnosed with MDD according to DSM IV without psychotic symptoms
HAM-D17 > or = 18 on inclusion
Patients receiving treatment for the first time or changing treatment based on their doctor's decision

Key exclusion criteria (2 listed)

Subjects with potentially problematic compliance
Subjects participating in an interventional trial within the last 3 months

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
CohortCohort (Patients diagnosed with MDD who are either changing treatment or have never received treatment).	Other	Single group

Primary outcome

Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)
Time frame: Week 12
Remission according to HAM-D: HAM-D17 score less than or equal to (=<) 7 or a HAM-D7 score =< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.

3 secondary outcomes

Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)
Time frame: Week 12
Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)
Time frame: Baseline, Week 12
Number of Participants With Residual Symptoms in Case of Non Remission
Time frame: Week 12

Results and safety

Results posted to the registry on 31 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	851	845

Primary outcome: Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)

Time frame: Week 12. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Hamilton Depression Scale (HAM-D) n = 843
Value	54.4 (51.1 to 57.8)

Population analysed: Intent-to-treat (ITT) population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Protocol did not indicate primary or secondary endpoints and designation of endpoints as primary or secondary endpoints was arbitrary.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Major Depressive Disorder

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
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
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Not yet recruiting
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Major Depressive Disorder (MDD)

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.

Pfizer CT.gov Call Center study director

Pfizer

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder, run by Pfizer at 3 sites in Greece.

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 5 inclusion and 2 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 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D) (time frame: Week 12). 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 NCT00770289.

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 31 Aug 2012.