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NCT01469377 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
A Phase 2 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 819
- Enrollment target
NCT01469377 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 819 participants.
The verdict
NCT01469377, a Phase 2 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 819 participants
- Enrollment target
Study Summary
An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.
Interventions
- DRUG Placebo
- DRUG Cariprazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 819 participants |
| Start Date | 2011-12-15 |
| Est. Completion | 2013-12-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01469377
The ClinicalTrials.gov registry entry for NCT01469377 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 819 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01469377 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01469377 about?
NCT01469377 is a clinical study titled "Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder". An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a...
What is the current status of trial NCT01469377?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 819 participants. The study started on 2011-12-15. Estimated completion is 2013-12-12.
What interventions are being tested in trial NCT01469377?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).
Who is sponsoring clinical trial NCT01469377?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
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