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NCT00361166 · ClinicalTrials.gov registry record · Phase 2
Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
A Phase 2 study, sponsored by ACADIA Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
NCT00361166: Completed Phase 2 study, sponsored by ACADIA Pharmaceuticals.
NCT00361166 is a Phase 2 study that has completed, run by ACADIA Pharmaceuticals. The registered enrollment target is 400 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (201% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00361166, a Phase 2 study, has completed, sponsored by ACADIA Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine whether a combination of ACP-103 (the study medication) with either haloperidol or risperidone will show antipsychotic efficacy and that it is safe and well tolerated. Further purposes of this study are to determine whether ACP-103, in combination with either haloperidol or risperidone, will enhance their antipsychotic effectiveness, demonstrate effectiveness against the negative symptoms, improve motoric tolerability, and is safe and well tolerated. This is a seven-week study (one week screening and six weeks of study medication) where a total of 400 patients who meet entrance criteria will randomly be assigned to receive one of five groups of study treatments of either low dose haloperidol plus ACP-103, low dose haloperidol plus placebo (a substance similar to a sugar pill), low dose risperidone plus ACP-103, low dose risperidone plus placebo, or high dose risperidone plus placebo. The study will begin with with a three to seven day drug-free period followed by six weeks of a stable daily dosage of study medication. Study subjects will be treated as hospital in-patients during screening and for the first 14 days of the study. Study subjects will be closely monitored throughout the study.
Interventions
- DRUG ACP-103
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2005-08 |
| Est. Completion | 2007-03 |
| Phase | Phase 2 |
What the finished NCT00361166 record still lists
NCT00361166 is an interventional study that assigns participants to a tested intervention. The registered 400 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 (201% higher).
The record links to 0 conditions, and to 1 intervention - of which ACP-103 is the first listed.
NCT00361166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00361166 about?
NCT00361166 is a clinical study titled "Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone". The primary purpose of this study is to determine whether a combination of ACP-103 (the study medication) with either haloperidol or risperidone will show antipsychotic efficacy and that it is safe and well tolerated. Further purposes of this study are to determine whether ACP-103, in combination wi...
What is the current status of trial NCT00361166?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2005-08. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00361166?
The interventions under investigation include: ACP-103 (DRUG).
Who is sponsoring clinical trial NCT00361166?
This trial is sponsored by ACADIA Pharmaceuticals, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00361166's enrollment target sits among peer trials
400 96th of 2000 higher than 1,898 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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