Major Depressive Disorder
Conditions
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
Interventions
OTHERCohort
Cohort (Patients diagnosed with MDD who are either changing treatment or have never received treatment).
Sponsors
Pfizer
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 851 |
| Total | 851 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 6 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age Continuous | 46.2 years STANDARD_DEVIATION 13.2 |
| Sex/Gender, Customized Female | 528 participants |
| Sex/Gender, Customized Male | 322 participants |
| Sex/Gender, Customized Not available | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hamilton Depression Scale (HAM-D) | Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D) | 54.4 Percentage of participants |
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hamilton Depression Scale (HAM-D) | Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) | Week 12 | 7.31 units on a scale | Standard Deviation 6.03 |
| Hamilton Depression Scale (HAM-D) | Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) | Baseline | 25.18 units on a scale | Standard Deviation 5.38 |
| Hamilton Depression Scale (HAM-D) | Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) | Change from baseline at Week 12 | 17.89 units on a scale | Standard Deviation 6.74 |
| Hamilton Depression Scale (HAM-D7) | Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) | Week 12 | 4.07 units on a scale | Standard Deviation 3.51 |
| Hamilton Depression Scale (HAM-D7) | Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) | Baseline | 13.53 units on a scale | Standard Deviation 3.22 |
| Hamilton Depression Scale (HAM-D7) | Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) | Change from baseline at Week 12 | 9.48 units on a scale | Standard Deviation 3.82 |
| Beck Depression Inventory (BDI) | Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) | Baseline | 31.45 units on a scale | Standard Deviation 8.95 |
| Beck Depression Inventory (BDI) | Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) | Change from baseline at Week 12 | 22.42 units on a scale | Standard Deviation 10.02 |
| Beck Depression Inventory (BDI) | Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) | Week 12 | 9.03 units on a scale | Standard Deviation 8.03 |
Comparison: Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.p-value: <0.000195% CI: [0.886, 0.911]Pearson's correlation
Comparison: Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.p-value: <0.000195% CI: [0.771, 0.82]Pearson's correlation
Comparison: Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.p-value: <0.000195% CI: [0.736, 0.791]Pearson's correlation
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hamilton Depression Scale (HAM-D) | Number of Participants With Residual Symptoms in Case of Non Remission | Emotional disorders | 59 participants |
| Hamilton Depression Scale (HAM-D) | Number of Participants With Residual Symptoms in Case of Non Remission | Sleep disorders | 35 participants |
| Hamilton Depression Scale (HAM-D) | Number of Participants With Residual Symptoms in Case of Non Remission | Behavioral disorders | 22 participants |
| Hamilton Depression Scale (HAM-D) | Number of Participants With Residual Symptoms in Case of Non Remission | Anxiety disorders | 22 participants |
| Hamilton Depression Scale (HAM-D) | Number of Participants With Residual Symptoms in Case of Non Remission | Psychosomatic disorders | 20 participants |
| Hamilton Depression Scale (HAM-D) | Number of Participants With Residual Symptoms in Case of Non Remission | Sexual disorders | 4 participants |
| Hamilton Depression Scale (HAM-D) | Number of Participants With Residual Symptoms in Case of Non Remission | No improvement | 3 participants |
| Hamilton Depression Scale (HAM-D) | Number of Participants With Residual Symptoms in Case of Non Remission | Psychotic disorders | 1 participants |
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hamilton Depression Scale (HAM-D) | Percentage of Participants With Remission Based on Beck Depression Inventory (BDI) | 64.6 Percentage of participants |