Trial Outcomes & Findings for Study Comparing Remission Rates, in Patients With Major Depressive Disorder (MDD) (NCT NCT00770289)
NCT ID: NCT00770289
Last Updated: 2012-08-31
Results Overview
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.
COMPLETED
851 participants
Week 12
2012-08-31
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
851
|
|
Overall Study
COMPLETED
|
845
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Other
|
6
|
Baseline Characteristics
Study Comparing Remission Rates, in Patients With Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
All Participants
n=851 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.
|
|---|---|
|
Age Continuous
|
46.2 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
528 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
322 participants
n=5 Participants
|
|
Sex/Gender, Customized
Not available
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Hamilton Depression Scale (HAM-D)
n=843 Participants
Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7.
|
Hamilton Depression Scale (HAM-D7)
Participants who were administered HAM-D7, a subset of clinician-administered rating scale HAM-D17.
|
Beck Depression Inventory (BDI)
Participants who were administered BDI.
|
|---|---|---|---|
|
Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)
|
54.4 Percentage of participants
Interval 51.1 to 57.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Hamilton Depression Scale (HAM-D)
n=842 Participants
Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7.
|
Hamilton Depression Scale (HAM-D7)
Participants who were administered HAM-D7, a subset of clinician-administered rating scale HAM-D17.
|
Beck Depression Inventory (BDI)
Participants who were administered BDI.
|
|---|---|---|---|
|
Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)
|
64.6 Percentage of participants
Interval 61.4 to 67.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Hamilton Depression Scale (HAM-D)
n=851 Participants
Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7.
|
Hamilton Depression Scale (HAM-D7)
n=851 Participants
Participants who were administered HAM-D7, a subset of clinician-administered rating scale HAM-D17.
|
Beck Depression Inventory (BDI)
n=850 Participants
Participants who were administered BDI.
|
|---|---|---|---|
|
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
|
9.48 units on a scale
Standard Deviation 3.82
|
22.42 units on a scale
Standard Deviation 10.02
|
|
Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)
Baseline
|
25.18 units on a scale
Standard Deviation 5.38
|
13.53 units on a scale
Standard Deviation 3.22
|
31.45 units on a scale
Standard Deviation 8.95
|
|
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
|
4.07 units on a scale
Standard Deviation 3.51
|
9.03 units on a scale
Standard Deviation 8.03
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Hamilton Depression Scale (HAM-D)
n=378 Participants
Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7.
|
Hamilton Depression Scale (HAM-D7)
Participants who were administered HAM-D7, a subset of clinician-administered rating scale HAM-D17.
|
Beck Depression Inventory (BDI)
Participants who were administered BDI.
|
|---|---|---|---|
|
Number of Participants With Residual Symptoms in Case of Non Remission
Emotional disorders
|
59 participants
|
—
|
—
|
|
Number of Participants With Residual Symptoms in Case of Non Remission
Sleep disorders
|
35 participants
|
—
|
—
|
|
Number of Participants With Residual Symptoms in Case of Non Remission
Behavioral disorders
|
22 participants
|
—
|
—
|
|
Number of Participants With Residual Symptoms in Case of Non Remission
Anxiety disorders
|
22 participants
|
—
|
—
|
|
Number of Participants With Residual Symptoms in Case of Non Remission
Psychosomatic disorders
|
20 participants
|
—
|
—
|
|
Number of Participants With Residual Symptoms in Case of Non Remission
Sexual disorders
|
4 participants
|
—
|
—
|
|
Number of Participants With Residual Symptoms in Case of Non Remission
No improvement
|
3 participants
|
—
|
—
|
|
Number of Participants With Residual Symptoms in Case of Non Remission
Psychotic disorders
|
1 participants
|
—
|
—
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER