Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Forest Laboratories.
NCT01469377 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 819 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (516% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
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 |
What the finished NCT01469377 record still lists
NCT01469377 is an interventional study that assigns participants to a tested intervention. The registered 819 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (516% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01469377 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01469377's enrollment target sits among peer trials
819 36th of 2000 higher than 1,965 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
- NCT04028687 · 820 participants
MDR - PMCF Study for Taperloc Complete Stems
- NCT04613440 · 820 participants · NA
FaCT Trial (Facilitated Cascade Testing Trial)
- NCT04910269 · 820 participants · Phase 3
Outpatient Treatment With Anti-Coronavirus Immunoglobulin
- NCT04846959 · 818 participants
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
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