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

Major Depressive Disorder Clinical Trial

— B2411003  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770289
• Other study ID #: 0600B-102374
• Secondary ID: B2411003
• Status: Completed
• Phase: N/A
• First received: October 8, 2008
• Last updated: August 1, 2012
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical 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. The evaluation will involve the use of HAM-D 17, and HAM-D 7 questionnaires and the comparison of those questionnaires.

Description:

12 weeks random

Recruitment information / eligibility

• Status: Completed
• Enrollment: 851
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subjects with potentially problematic compliance

• Subjects participating in an interventional trial within the last 3 months

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Greece	Pfizer Investigational Site	Haidari	Athens
Greece	Pfizer Investigational Site	Haidari	Athens
Greece	Pfizer Investigational Site	Ilissia	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 12	No
Secondary	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.	Week 12	No
Secondary	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.	Baseline, Week 12	No
Secondary	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.	Week 12	No

External Links

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