Depressive Disorder, Major
Conditions
Keywords
Major Depressive Disorder, Depression, Anxiety
Brief summary
The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a patient management program, which aims to help patients achieve successful outcomes by reinforcing physician treatment efforts, providing feedback to treating physicians, and encouraging better physician-patient communications.
Interventions
DRUGVenlafaxine ER
BEHAVIORALDialogues Time to Talk Program
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently experiencing a major depressive episode, which requires the initiation of antidepressant drug treatment or a change in current antidepressant drug treatment * At least 18 years of age
Exclusion criteria
* History or presence of bipolar disorder * Current treatment with venlafaxine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Responding Very Satisfied on Satisfaction With Depression Care Scale (SDCS) | 112 days | Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). Very satisfied was defined as a score of greater than or equal to 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) Score | 112 days | PGI-I is a global rating scale that measures disease improvement. Using a 7-point scale (1=very much improved, 7=very much worse), the patients rate how much their illness has improved or worsened relative to their baseline status. |
| Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks | Baseline and 112 days | WHO 5-item Well Being Index (WHO-5) evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0=worst possible quality of life, 25=best possible quality of life). Change = 16 week adjusted mean WHO-5 score minus baseline. |
| Number of Patients Compliant With Therapy | 112 days | Patient compliance with therapy was assessed using a Medical Adherence Questionnaire (MAQ). MAQ consisted of 5 levels of compliance with taking medicine: Never miss, Sometimes miss, Miss half of the time, Miss most of the time, Always miss. Compliance with therapy was defined as a response of Never miss or Sometimes miss. |
| Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks | Baseline and 112 days | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2 or 4 scale (0 = none/absent and 4 = most severe) with a maximum total score of 50. Change = 16 week adjusted mean HAM-D17 score minus baseline. |
| Change in Sheehan Disability Scale Score From Baseline to 16 Weeks | Baseline and 112 days | The Sheehan Disability Scale is a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life and Family Life/Home Responsibilities. The patient rates the extent to which each of these domains are impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired and 10=extremely impaired) for a total maximum score of 30. |
| Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | 112 days | CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1=very much improved, 7=very much worse). |
| Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks | Baseline and 112 days | IDS-SR is a patient self-administered tool used to measure the severity of depressive symptoms. Each symptom is assessed on a scale of 0 to 3 (0=absence of symptom to 3=sever symptom) for a total maximum score of 84. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited in the United States from June 2006 to March 2007.
Pre-assignment details
Subjects were enrolled according to the inclusion / exclusion criteria. There was not a screening period.
Participants by arm
| Arm | Count |
|---|---|
| Venlafaxine Extended Release (ER) 75-225 mg per day | 269 |
| Venlafaxine Extended Release (ER) Plus Dialogues Venlafaxine ER 75-225 mg per day plus Dialogues Time to Talk program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication. | 268 |
| Total | 537 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 34 | 45 |
| Overall Study | Death | 0 | 3 |
| Overall Study | Lack of Efficacy | 4 | 6 |
| Overall Study | Lost to Follow-up | 23 | 20 |
| Overall Study | Physician Decision | 3 | 6 |
| Overall Study | Protocol Deviation | 9 | 4 |
| Overall Study | Protocol Violation | 6 | 3 |
| Overall Study | Sponsor Request | 0 | 1 |
| Overall Study | Withdrawal by Subject | 18 | 24 |
Baseline characteristics
| Characteristic | Venlafaxine Extended Release (ER) | Venlafaxine Extended Release (ER) Plus Dialogues | Total |
|---|---|---|---|
| Age Continuous | 44.13 years STANDARD_DEVIATION 13.59 | 45.25 years STANDARD_DEVIATION 13.83 | 44.69 years STANDARD_DEVIATION 13.71 |
| Sex: Female, Male Female | 199 Participants | 190 Participants | 389 Participants |
| Sex: Female, Male Male | 70 Participants | 78 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 209 / 269 | 214 / 268 |
| serious Total, serious adverse events | 10 / 269 | 18 / 268 |
Outcome results
Primary
Number of Patients Responding Very Satisfied on Satisfaction With Depression Care Scale (SDCS)
Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). Very satisfied was defined as a score of greater than or equal to 8.
Time frame: 112 days
Population: The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venlafaxine Extended Release (ER) | Number of Patients Responding Very Satisfied on Satisfaction With Depression Care Scale (SDCS) | 160 participants |
| Venlafaxine Extended Release (ER) Plus Dialogues | Number of Patients Responding Very Satisfied on Satisfaction With Depression Care Scale (SDCS) | 138 participants |
p-value: 0.218Chi-squared
Secondary
Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2 or 4 scale (0 = none/absent and 4 = most severe) with a maximum total score of 50. Change = 16 week adjusted mean HAM-D17 score minus baseline.
Time frame: Baseline and 112 days
Population: The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venlafaxine Extended Release (ER) | Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks | -10.87 units on scale | Standard Error 0.39 |
| Venlafaxine Extended Release (ER) Plus Dialogues | Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks | -11.03 units on scale | Standard Error 0.4 |
p-value: 0.7695% CI: [-0.92, 1.25]ANCOVA
Secondary
Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks
IDS-SR is a patient self-administered tool used to measure the severity of depressive symptoms. Each symptom is assessed on a scale of 0 to 3 (0=absence of symptom to 3=sever symptom) for a total maximum score of 84.
Time frame: Baseline and 112 days
Population: The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venlafaxine Extended Release (ER) | Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks | -17.75 units on scale | Standard Error 0.71 |
| Venlafaxine Extended Release (ER) Plus Dialogues | Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks | -17.50 units on scale | Standard Error 0.73 |
p-value: 0.80595% CI: [-2.24, 1.74]ANCOVA
Secondary
Change in Sheehan Disability Scale Score From Baseline to 16 Weeks
The Sheehan Disability Scale is a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life and Family Life/Home Responsibilities. The patient rates the extent to which each of these domains are impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired and 10=extremely impaired) for a total maximum score of 30.
Time frame: Baseline and 112 days
Population: The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venlafaxine Extended Release (ER) | Change in Sheehan Disability Scale Score From Baseline to 16 Weeks | -7.99 units on scale | Standard Error 0.45 |
| Venlafaxine Extended Release (ER) Plus Dialogues | Change in Sheehan Disability Scale Score From Baseline to 16 Weeks | -6.99 units on scale | Standard Error 0.47 |
p-value: 0.12395% CI: [-2.27, 0.27]ANCOVA
Secondary
Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks
WHO 5-item Well Being Index (WHO-5) evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0=worst possible quality of life, 25=best possible quality of life). Change = 16 week adjusted mean WHO-5 score minus baseline.
Time frame: Baseline and 112 days
Population: The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venlafaxine Extended Release (ER) | Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks | 6.86 units on scale | Standard Error 0.35 |
| Venlafaxine Extended Release (ER) Plus Dialogues | Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks | 6.97 units on scale | Standard Error 0.36 |
p-value: 0.82995% CI: [-1.09, 0.87]ANCOVA
Secondary
Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1=very much improved, 7=very much worse).
Time frame: 112 days
Population: The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. Data not available for one participant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Venlafaxine Extended Release (ER) | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 2 (much improved) | 84 patients |
| Venlafaxine Extended Release (ER) | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 4 (no change) | 24 patients |
| Venlafaxine Extended Release (ER) | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 1 (very much improved) | 82 patients |
| Venlafaxine Extended Release (ER) | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 5 (worse) | 11 patients |
| Venlafaxine Extended Release (ER) | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 6 (much worse) | 2 patients |
| Venlafaxine Extended Release (ER) | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 3 (improved) | 50 patients |
| Venlafaxine Extended Release (ER) | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 7 (very much worse) | 0 patients |
| Venlafaxine Extended Release (ER) Plus Dialogues | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 3 (improved) | 49 patients |
| Venlafaxine Extended Release (ER) Plus Dialogues | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 5 (worse) | 8 patients |
| Venlafaxine Extended Release (ER) Plus Dialogues | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 1 (very much improved) | 81 patients |
| Venlafaxine Extended Release (ER) Plus Dialogues | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 2 (much improved) | 75 patients |
| Venlafaxine Extended Release (ER) Plus Dialogues | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 7 (very much worse) | 0 patients |
| Venlafaxine Extended Release (ER) Plus Dialogues | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 4 (no change) | 21 patients |
| Venlafaxine Extended Release (ER) Plus Dialogues | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI - 6 (much worse) | 5 patients |
Comparison: CGI-I raw scores (range 1-7) analyzed by generalized Cochran-Mantel-Haenszel (CMH) test, stratified by study center using the ridit scoring option.p-value: 0.961Cochran-Mantel-Haenszel
Secondary
Number of Patients Compliant With Therapy
Patient compliance with therapy was assessed using a Medical Adherence Questionnaire (MAQ). MAQ consisted of 5 levels of compliance with taking medicine: Never miss, Sometimes miss, Miss half of the time, Miss most of the time, Always miss. Compliance with therapy was defined as a response of Never miss or Sometimes miss.
Time frame: 112 days
Population: The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venlafaxine Extended Release (ER) | Number of Patients Compliant With Therapy | 248 participants |
| Venlafaxine Extended Release (ER) Plus Dialogues | Number of Patients Compliant With Therapy | 232 participants |
p-value: 0.728Chi-squared
Secondary
Patient Global Impression of Improvement (PGI-I) Score
PGI-I is a global rating scale that measures disease improvement. Using a 7-point scale (1=very much improved, 7=very much worse), the patients rate how much their illness has improved or worsened relative to their baseline status.
Time frame: 112 days
Population: The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venlafaxine Extended Release (ER) | Patient Global Impression of Improvement (PGI-I) Score | 2.33 units on scale | Standard Error 0.08 |
| Venlafaxine Extended Release (ER) Plus Dialogues | Patient Global Impression of Improvement (PGI-I) Score | 2.51 units on scale | Standard Error 0.09 |
p-value: 0.14895% CI: [-0.41, 0.06]ANCOVA