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NCT00488618 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
A Phase 2 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 238
- Enrollment target
NCT00488618: Completed Phase 2 study, sponsored by Forest Laboratories.
NCT00488618 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 238 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00488618, a Phase 2 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 238 participants
- Enrollment target
Study Summary
This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo
Primary Outcome
The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a
Interventions
- DRUG Placebo
- DRUG Cariprazine (RGH-188)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
What the finished NCT00488618 record still lists
NCT00488618 is an interventional study that assigns participants to a tested intervention. The registered 238 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 (79% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00488618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00488618 about?
NCT00488618 is a clinical study titled "Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania". This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to...
What is the current status of trial NCT00488618?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 238 participants. The study started on 2007-06. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00488618?
The interventions under investigation include: Placebo (DRUG), Cariprazine (RGH-188) (DRUG).
Who is sponsoring clinical trial NCT00488618?
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 NCT00488618's enrollment target sits among peer trials
238 255th of 2000 higher than 1,746 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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