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NCT01371734 · ClinicalTrials.gov registry record · Phase 3
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
A Phase 3 study of Major Depressive Disorder, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 363
- Enrollment target
- 20
- Study locations
NCT01371734: Completed Phase 3 study of Major Depressive Disorder, sponsored by Pfizer.
NCT01371734 is a Phase 3 study of Major Depressive Disorder that has completed, run by Pfizer. The registered enrollment target is 363 participants, roughly in line with the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01371734, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 363 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
Primary Outcome
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Desvenlafaxine Succinate Sustained-Release
Study Locations (20)
Florida
- SJS Clinical Research, Inc. - Destin
- Sarkis Clinical Trials - Gainesville
- Clinical Neuroscience Solutions - Jacksonville
- Medical Research Group of Central Florida - Orange City
- Millenia Psychiatry & Research, Inc. - Orlando
- Janus Center for Psychiatric Research - West Palm Beach
Connecticut
- Bliss Basement Pharmacy - Hartford Hospital - Hartford
- Institute of Living/Hartford Hospital - Hartford
- Institute of Living - Hartford
Alabama
- Children's Hospital of Alabama Laboratory - Birmingham
- The University of Alabama at Birmingham, Office of Psychiatric Research - Birmingham
Illinois
- Capstone Clinical Research - Libertyville
- AMR-Baber Research Inc. - Naperville
Louisiana
- Louisiana State University Health Sciences Center-Psychopharmacology Research Clinic - Shreveport
- Drug:University Health Shreveport Outpatient - Shreveport
Arizona
- Center for Advanced Improvement - Tucson
California
- Sun Valley Research Center - Imperial
Colorado
- MCB Clinical Research Centers - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
What the finished NCT01371734 record still lists
NCT01371734 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01371734 names 20 study sites across 10 states, led by Florida, Connecticut, Alabama.
Frequently Asked Questions
What is clinical trial NCT01371734 about?
NCT01371734 is a clinical study titled "A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD". This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
What is the current status of trial NCT01371734?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 363 participants. The study started on 2011-08. Estimated completion is 2015-09.
What conditions does trial NCT01371734 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT01371734?
The interventions under investigation include: Placebo (DRUG), Desvenlafaxine Succinate Sustained-Release (DRUG).
Who is sponsoring clinical trial NCT01371734?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01371734 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01371734's enrollment target sits among peer trials
363 45th of 282 higher than 238 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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.
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