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NCT01838876 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 442
- Enrollment target
NCT01838876: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT01838876 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 442 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01838876, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 442 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receivi
Interventions
- DRUG Cariprazine
- DRUG Antidepressant Therapy (ADT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2013-04-29 |
| Est. Completion | 2015-07-27 |
| Phase | Phase 3 |
What the finished NCT01838876 record still lists
NCT01838876 is an interventional study that assigns participants to a tested intervention. The registered 442 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 (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Cariprazine is the first listed.
NCT01838876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01838876 about?
NCT01838876 is a clinical study titled "Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder". The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).
What is the current status of trial NCT01838876?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 442 participants. The study started on 2013-04-29. Estimated completion is 2015-07-27.
What interventions are being tested in trial NCT01838876?
The interventions under investigation include: Cariprazine (DRUG), Antidepressant Therapy (ADT) (DRUG).
Who is sponsoring clinical trial NCT01838876?
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 NCT01838876's enrollment target sits among peer trials
442 867th of 2000 higher than 1,134 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
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