Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
Public ClinicalTrials.gov record NCT00361166. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double Blind, Multi-Center Study to Assess the Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol or Risperidone to Schizophrenic Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00361166
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2005
- Primary completion
- Not listed
- Completion
- Feb 28, 2007
- Last update posted
- Mar 21, 2007
2005 – 2007
United States locations
- U.S. sites
- 11
- U.S. states
- 4
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Cerritos | California | 90703 | — |
| Not listed | Garden Grove | California | 92845 | — |
| Not listed | Glendale | California | 91206 | — |
| Not listed | Paramount | California | 90723 | — |
| Not listed | Pico Rivera | California | 90660 | — |
| Not listed | San Diego | California | 92123 | — |
| Not listed | San Diego | California | 92126 | — |
| Not listed | Washington D.C. | District of Columbia | 20016 | — |
| Not listed | St Louis | Missouri | 63118 | — |
| Not listed | Austin | Texas | 78756 | — |
| Not listed | Irving | Texas | 75062 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00361166, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2007 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00361166 live on ClinicalTrials.gov.