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| ID | Type | Description | Link |
|---|---|---|---|
| B2411003 | Other Identifier | Pfizer |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort | Other | Cohort (Patients diagnosed with MDD who are either changing treatment or have never received treatment). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with MDD who are either changing treatment or have never received treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Haidari | Athens | 12461 | Greece | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Out of 851 participants, data for the baseline measure, age, was available only for 849 participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
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There were no adverse events collected in this observational non-interventional study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion. |
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Protocol did not indicate primary or secondary endpoints and designation of endpoints as primary or secondary endpoints was arbitrary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015331 | Cohort Studies |
| ID | Term |
|---|---|
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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| 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. | 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. | Week 12 |
| Haidari |
| Athens |
| 12462 |
| Greece |
| Pfizer Investigational Site | Ilissia | Athens | 11528 | Greece |
| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Number | participants |
|
Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7. |
|
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
|
|
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| 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. | ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available at baseline and were evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
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| 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. | 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. | Posted | Number | participants | Week 12 |
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| 0 |
| 0 |
| 0 |
| 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Change from baseline at Week 12 |
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Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires. |
| Pearson's correlation |
| <0.0001 |
The statistical testing was done at alpha = 0.05. |
| Pearson's correlation coefficient |
| 0.797 |
| 2-Sided |
| 95 |
| 0.771 |
| 0.820 |
| No |
| Superiority or Other |
| Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires. | Pearson's correlation | <0.0001 | The statistical testing was done at alpha = 0.05. | Pearson's correlation coefficient | 0.765 | 2-Sided | 95 | 0.736 | 0.791 | No | Superiority or Other |
| Title | Measurements |
|---|---|
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| Anxiety disorders |
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| Psychosomatic disorders |
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| Sexual disorders |
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| No improvement |
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| Psychotic disorders |
|