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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 is a Phase 2 study that has completed, run by ACADIA Pharmaceuticals. The registered enrollment target is 400 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00361166
The ClinicalTrials.gov registry entry for NCT00361166 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ACADIA Pharmaceuticals, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ACP-103 is the first listed.
NCT00361166 reports 0 study locations.
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.
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