Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01111539 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Terminated
- Registry status
- Phase 3
- Development phase
- 211
- Enrollment target
NCT01111539 is a Phase 3 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 211 participants.
The verdict
NCT01111539, a Phase 3 study, was terminated before completion, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
Study Summary
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participant's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participant's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.
Interventions
- DRUG Escitalopram
- DRUG Aripiprazole
- DRUG Blinded capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2010-07-13 |
| Est. Completion | 2011-09-20 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01111539
The ClinicalTrials.gov registry entry for NCT01111539 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 211 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Escitalopram is the first listed.
NCT01111539 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01111539 about?
NCT01111539 is a clinical study titled "Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)". This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a trea...
What is the current status of trial NCT01111539?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2010-07-13. Estimated completion is 2011-09-20.
What interventions are being tested in trial NCT01111539?
The interventions under investigation include: Escitalopram (DRUG), Aripiprazole (DRUG), Blinded capsule (DRUG).
Who is sponsoring clinical trial NCT01111539?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.