Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00644358 · ClinicalTrials.gov registry record · Phase 3
A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 616
- Enrollment target
NCT00644358: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00644358 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 616 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00644358, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 616 participants
- Enrollment target
Study Summary
This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD. This study will enroll approximately 600 patients.
Primary Outcome
An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study med
Interventions
- DRUG vilazodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 616 participants |
| Start Date | 2007-12-31 |
| Est. Completion | 2009-05-31 |
| Phase | Phase 3 |
What the finished NCT00644358 record still lists
NCT00644358 is an interventional study that assigns participants to a tested intervention. The registered 616 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which vilazodone is the first listed.
NCT00644358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00644358 about?
NCT00644358 is a clinical study titled "A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)". This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD. This study will enroll approximately 600 patients.
What is the current status of trial NCT00644358?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 616 participants. The study started on 2007-12-31. Estimated completion is 2009-05-31.
What interventions are being tested in trial NCT00644358?
The interventions under investigation include: vilazodone (DRUG).
Who is sponsoring clinical trial NCT00644358?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00644358's enrollment target sits among peer trials
616 593rd of 2000 higher than 1,408 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04813185 · 616 participants · NA
Preventing Retaliatory Gun Violence in Violently Injured Adults
- NCT06105957 · 616 participants · NA
Optimal Digital Weight Loss Treatment for Rural Individuals
- NCT06162221 · 616 participants · Phase 1
Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC
- NCT02610179 · 617 participants · NA
Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI