Study Comparing Remission Rates, in Patients With Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Interventions
- Other: Cohort
- Registration Number
- NCT00770289
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
12 weeks random
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 851
- 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
- Subjects with potentially problematic compliance
- Subjects participating in an interventional trial within the last 3 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single group Cohort -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Remission Based on Beck Depression Inventory (BDI) Week 12 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.
Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) Baseline, Week 12 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.
Number of Participants With Residual Symptoms in Case of Non Remission Week 12 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇷Ilissia, Athens, Greece