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NCT00854100 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
A Phase 2 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 231
- Enrollment target
NCT00854100: Completed Phase 2 study, sponsored by Forest Laboratories.
NCT00854100 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 231 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00854100, a Phase 2 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 231 participants
- Enrollment target
Study Summary
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.
Primary Outcome
The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to
Interventions
- DRUG Antidepressant + placebo
- DRUG Antidepressant + cariprazine (0.1-0.3 mg/day)
- DRUG Antidepressant + cariprazine (1-2 mg/d)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2009-06-30 |
| Est. Completion | 2010-12-06 |
| Phase | Phase 2 |
What the finished NCT00854100 record still lists
NCT00854100 is an interventional study that assigns participants to a tested intervention. The registered 231 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 (74% higher).
The record links to 0 conditions, and to 3 interventions - of which Antidepressant + placebo is the first listed.
NCT00854100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00854100 about?
NCT00854100 is a clinical study titled "Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder". This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.
What is the current status of trial NCT00854100?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 231 participants. The study started on 2009-06-30. Estimated completion is 2010-12-06.
What interventions are being tested in trial NCT00854100?
The interventions under investigation include: Antidepressant + placebo (DRUG), Antidepressant + cariprazine (0.1-0.3 mg/day) (DRUG), Antidepressant + cariprazine (1-2 mg/d) (DRUG).
Who is sponsoring clinical trial NCT00854100?
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 NCT00854100's enrollment target sits among peer trials
231 257th of 2000 higher than 1,744 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
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