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

NCT00770289 | Completed Results

• 2 other identifiers: 0600B-102374B2411003
• Study Type: observational
• Target: 851
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)

  Week 12

• Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)

  Baseline, Week 12

• Number of Participants With Residual Symptoms in Case of Non Remission

  Week 12

Study Arms (1)

Single group

Other: Cohort

Interventions

Cohort OTHER

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

Single group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Outpatients
• years old
• Patients diagnosed with MDD according to DSM IV without psychotic symptoms
• Patients receiving treatment for the first time or changing treatment based on their doctor's decision

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Haidari, Athens, 12461, Greece

Location

Pfizer Investigational Site

Haidari, Athens, 12462, Greece

Location

Pfizer Investigational Site

Ilissia, Athens, 11528, Greece

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

Protocol did not indicate primary or secondary endpoints and designation of endpoints as primary or secondary endpoints was arbitrary.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 31, 2012
• Results First Posted: August 31, 2012

Record last verified: 2012-08

Locations

GR (3)