Trial · NCT00401726
Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program
NCT00401726, Phase 4, Completed, Wyeth is now a wholly owned subsidiary of Pfizer; results first posted 2010-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program. Trials, record NCT00401726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00401726
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program
- NCT number
- NCT00401726
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 537 participants, actual
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Conditions
- Depressive Disorder, Major
- Interventions
- Venlafaxine ER, Dialogues Time to Talk Program
- First posted
- 2006-11-20
- Last updated
- 2012-04-23
- Results first posted
- 2010-06-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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". |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Responding Very Satisfied on Satisfaction With Depression Care Scale (SDCS) | 112 days | 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. | participants | NUMBER |
| SECONDARY | Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks | Baseline and 112 days | 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. | units on scale | MEAN |
| SECONDARY | Patient Global Impression of Improvement (PGI-I) Score | 112 days | 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. | units on scale | MEAN |
| SECONDARY | Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks | Baseline and 112 days | 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. | units on scale | MEAN |
| SECONDARY | Number of Patients Compliant With Therapy | 112 days | 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. | participants | NUMBER |
| SECONDARY | Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks | Baseline and 112 days | 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. | units on scale | MEAN |
| SECONDARY | Change in Sheehan Disability Scale Score From Baseline to 16 Weeks | Baseline and 112 days | 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. | units on scale | MEAN |
| SECONDARY | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | 112 days | 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. | patients | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Responding Very Satisfied on Satisfaction With Depression Care Scale (SDCS) | Venlafaxine Extended Release (ER) | 160 | participants | ||
| Number of Patients Responding Very Satisfied on Satisfaction With Depression Care Scale (SDCS) | Venlafaxine Extended Release (ER) Plus Dialogues | 138 | participants | ||
| Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks | Venlafaxine Extended Release (ER) | -10.87 | Standard Error 0.39 | units on scale | |
| Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks | Venlafaxine Extended Release (ER) Plus Dialogues | -11.03 | Standard Error 0.40 | units on scale | |
| Patient Global Impression of Improvement (PGI-I) Score | Venlafaxine Extended Release (ER) | 2.33 | Standard Error 0.08 | units on scale | |
| Patient Global Impression of Improvement (PGI-I) Score | Venlafaxine Extended Release (ER) Plus Dialogues | 2.51 | Standard Error 0.09 | units on scale | |
| Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks | Venlafaxine Extended Release (ER) | 6.86 | Standard Error 0.35 | units on scale | |
| Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks | Venlafaxine Extended Release (ER) Plus Dialogues | 6.97 | Standard Error 0.36 | units on scale | |
| Number of Patients Compliant With Therapy | Venlafaxine Extended Release (ER) | 248 | participants | ||
| Number of Patients Compliant With Therapy | Venlafaxine Extended Release (ER) Plus Dialogues | 232 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Venlafaxine Extended Release (ER) | 269 | |
| Overall Study | STARTED | Venlafaxine Extended Release (ER) Plus Dialogues | 268 | |
| Overall Study | COMPLETED | Venlafaxine Extended Release (ER) | 172 | |
| Overall Study | COMPLETED | Venlafaxine Extended Release (ER) Plus Dialogues | 156 | |
| Overall Study | NOT COMPLETED | Venlafaxine Extended Release (ER) | 97 | |
| Overall Study | NOT COMPLETED | Venlafaxine Extended Release (ER) Plus Dialogues | 112 |
Source ClinicalTrials.gov
Adverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthenia | General disorders | Venlafaxine Extended Release (ER) | 14 | 269 | |
| other | Asthenia | General disorders | Venlafaxine Extended Release (ER) Plus Dialogues | 19 | 268 | |
| other | Headache | General disorders | Venlafaxine Extended Release (ER) | 30 | 269 | |
| other | Headache | General disorders | Venlafaxine Extended Release (ER) Plus Dialogues | 20 | 268 | |
| other | Infection | General disorders | Venlafaxine Extended Release (ER) | 17 | 269 | |
| other | Infection | General disorders | Venlafaxine Extended Release (ER) Plus Dialogues | 12 | 268 | |
| other | Cardiovascular general | Cardiac disorders | Venlafaxine Extended Release (ER) | 28 | 269 | |
| other | Cardiovascular general | Cardiac disorders | Venlafaxine Extended Release (ER) Plus Dialogues | 27 | 268 | |
| other | Constipation | Gastrointestinal disorders | Venlafaxine Extended Release (ER) | 11 | 269 | |
| other | Constipation | Gastrointestinal disorders | Venlafaxine Extended Release (ER) Plus Dialogues | 34 | 268 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Venlafaxine Extended Release (ER) | ||
| Total, all-cause mortality | Venlafaxine Extended Release (ER) Plus Dialogues | ||
| Total, other adverse events | Venlafaxine Extended Release (ER) | 209 | 269 |
| Total, other adverse events | Venlafaxine Extended Release (ER) Plus Dialogues | 214 | 268 |
| Total, serious adverse events | Venlafaxine Extended Release (ER) | 10 | 269 |
| Total, serious adverse events | Venlafaxine Extended Release (ER) Plus Dialogues | 18 | 268 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Venlafaxine Extended Release (ER) vs Venlafaxine Extended Release (ER) Plus Dialogues: Number of Patients Compliant With Therapy | Trial comparisons |
| Venlafaxine Extended Release (ER) vs Venlafaxine Extended Release (ER) Plus Dialogues: Number of Patients Responding Very Satisfied on Satisfaction With Depression Care Scale (SDCS) | Trial comparisons |
| Venlafaxine Extended Release (ER) vs Venlafaxine Extended Release (ER) Plus Dialogues: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00401726
GET https://conductscience.org/api/trials/v1/NCT00401726/results?page=2