Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01715805 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,022
- Enrollment target
NCT01715805: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT01715805 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 1,022 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01715805, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,022 participants
- Enrollment target
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
Primary Outcome
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.
Interventions
- DRUG Placebo
- DRUG Cariprazine
- DRUG Antidepressant Therapy (ADT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,022 participants |
| Start Date | 2012-11-15 |
| Est. Completion | 2016-06-24 |
| Phase | Phase 3 |
What the finished NCT01715805 record still lists
NCT01715805 is an interventional study that assigns participants to a tested intervention. Its 1,022 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01715805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01715805 about?
NCT01715805 is a clinical study titled "Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)". 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
What is the current status of trial NCT01715805?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,022 participants. The study started on 2012-11-15. Estimated completion is 2016-06-24.
What interventions are being tested in trial NCT01715805?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG), Antidepressant Therapy (ADT) (DRUG).
Who is sponsoring clinical trial NCT01715805?
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 NCT01715805's enrollment target sits among peer trials
1,022 290th of 2000 higher than 1,711 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
- NCT07216703 · 1,023 participants · Phase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
- NCT06888011 · 1,024 participants · NA
iAmHealthy Clinical Practice Guideline (CPG)
- NCT02178163 · 1,020 participants · NA
Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer
- NCT05225428 · 1,020 participants · NA
Video Education With Result Dependent dIsclosure
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