Phase 4
Completed N=537
Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT00401726 ↗
Enrolled (actual)
537
Serious AEs
5.2%
Results posted
Jun 2010
Primary outcomePrimary: Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS) — 160; 138 participants — p=0.218
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS) |
160; 138 | 0.218 |
| SECONDARY Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks |
-10.87; -11.03 | 0.76 |
| SECONDARY Patient Global Impression of Improvement (PGI-I) Score |
2.33; 2.51 | 0.148 |
| SECONDARY Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks |
6.86; 6.97 | 0.829 |
| SECONDARY Number of Patients Compliant With Therapy |
248; 232 | 0.728 |
| SECONDARY Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks |
-17.75; -17.50 | 0.805 |
| SECONDARY Change in Sheehan Disability Scale Score From Baseline to 16 Weeks |
-7.99; -6.99 | 0.123 |
| SECONDARY Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks |
82; 81; 84; 75; 50; 49 | 0.961 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00401726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.