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NCT03739203 · ClinicalTrials.gov registry record · Phase 3
The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
A Phase 3 study of Major Depressive Disorder, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 752
- Enrollment target
- 20
- Study locations
NCT03739203: Completed Phase 3 study of Major Depressive Disorder, sponsored by AbbVie.
NCT03739203 is a Phase 3 study of Major Depressive Disorder that has completed, run by AbbVie. The registered enrollment target is 752 participants, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03739203, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 752 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.
Primary Outcome
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cariprazine
- DRUG Antidepressant Therapy (ADT)
Study Locations (20)
California
- California Pharmaceutical Research Institute /ID# 236731 - Anaheim
- Axiom Research /ID# 236267 - Colton
- Global Clinical Trials /ID# 235059 - Costa Mesa
- Collaborative Neuroscience Research - Orange County /ID# 237637 - Garden Grove
- Behavioral Research Specialists, LLC /ID# 236622 - Glendale
- Sun Valley Research Center /ID# 236560 - Imperial
- North County Clinical Research /ID# 235014 - Oceanside
- Excell Research, Inc /ID# 237717 - Oceanside
- NRC Research Institute /ID# 234632 - Orange
- Anderson Clinical Research /ID# 236624 - Redlands
- Syrentis Clinical Research /ID# 237408 - Santa Ana
- California Neuroscience Research Medical Group, Inc. /ID# 236636 - Sherman Oaks
- Schuster Medical Research Institute /ID# 236445 - Sherman Oaks
- Pacific Clinical Research Management Group /ID# 234378 - Upland
Florida
- Innovative Clinical Research /ID# 235186 - Fort Lauderdale
- Gulfcoast Clinical Research Center /ID# 236280 - Fort Myers
Alabama
- Harmonex /ID# 236936 - Dothan
Arkansas
- Woodland International Research Group /ID# 236349 - Little Rock
Colorado
- MCB Clinical Research Centers /ID# 236927 - Colorado Springs
Connecticut
- CT Clinical Research /ID# 234638 - Cromwell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 752 participants |
| Start Date | 2018-11-10 |
| Est. Completion | 2021-09-06 |
| Phase | Phase 3 |
What the finished NCT03739203 record still lists
NCT03739203 is an interventional study that assigns participants to a tested intervention. The registered 752 participants enrollment target is mid-sized for trials with a published cap, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (101% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03739203 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT03739203 about?
NCT03739203 is a clinical study titled "The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone". The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.
What is the current status of trial NCT03739203?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 752 participants. The study started on 2018-11-10. Estimated completion is 2021-09-06.
What conditions does trial NCT03739203 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT03739203?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG), Antidepressant Therapy (ADT) (DRUG).
Who is sponsoring clinical trial NCT03739203?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03739203 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03739203's enrollment target sits among peer trials
752 15th of 282 higher than 268 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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