An observational study in Major Depressive Disorder, sponsored by Pfizer. Completed at 3 sites in Greece. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-08-31.
Sponsored by Pfizer · Observational
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.
12 weeks random
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 851 is above the median of 150 across 653 observational studies indexed under Depressive Disorder.
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Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Patients diagnosed with MDD who are either changing treatment or have never received treatment.
Exclusion Criteria:
Other: Cohort
Cohort (Patients diagnosed with MDD who are either changing treatment or have never received treatment).
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.
Time frame: Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 12
| Milestone | All Participants |
|---|---|
| Started | 851 |
| Completed | 845 |
| Not completed | 6 |
| Withdrew: Other | 6 |
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.
| Percentage of participants | Hamilton Depression Scale (HAM-D) |
|---|---|
| Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D) | 54.4 (51.1 to 57.8) |
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.
| Percentage of participants | Beck Depression Inventory (BDI) |
|---|---|
| Percentage of Participants With Remission Based on Beck Depression Inventory (BDI) | 64.6 (61.4 to 67.8) |
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.
| units on a scale | Hamilton Depression Scale (HAM-D17) | Hamilton Depression Scale (HAM-D7) | Beck Depression Inventory (BDI) |
|---|---|---|---|
| Baseline | 25.18 ± 5.38 | 13.53 ± 3.22 | 31.45 ± 8.95 |
| Week 12 | 7.31 ± 6.03 | 4.07 ± 3.51 | 9.03 ± 8.03 |
| Change from baseline at Week 12 | 17.89 ± 6.74 | 9.48 ± 3.82 | 22.42 ± 10.02 |
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.
| participants | All Participants |
|---|---|
| Emotional disorders | 59 |
| Sleep disorders | 35 |
| Behavioral disorders | 22 |
| Anxiety disorders | 22 |
| Psychosomatic disorders | 20 |
| Sexual disorders | 4 |
| No improvement | 3 |
| Psychotic disorders | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | — | — | — |
| Age Continuous(years) | All Participants |
|---|---|
| Mean | 46.2 ± 13.2 |
| Sex/Gender, Customized(participants) | All Participants |
|---|---|
| Female | 528 |
| Male | 322 |
| Not available | 1 |
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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