SchizophreniaPhase 2NCT00361166
Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
A Phase 2 study testing ACP-103 in people with Schizophrenia, run by ACADIA Pharmaceuticals Inc. at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ACP-103
- How many people
- 400 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Aug 2005to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female subjects ages 18-65 diagnosed with schizophrenia
- experiencing an acute exacerbation of psychosis
- has had prior response to antipsychotic therapy within the previous 3 years
- female subjects must be of non-childbearing potential or must comply with double-barrier protection methods against conception
- ability of subject or caregiver or legally authorized representative to provide informed consent
- subjects must be hospitalized at screening and must be willing to remain in the hospital at least 14 days after baseline and must comply with all study events through completion of the study
Who cannot join
- inability of the subject or caregiver or legally authorized representative to provide consent
- any female subject who is pregnant or breast feeding
- any subject with concurrent mental illness or disability
- any subject considered to be a danger to themselves or others
- recent use of certain antipsychotics or other medications that might interfere with this study's medication
- abnormal clinical laboratory values
Show all 10Show fewer
- presence, or recent history, of serious medical conditions or drug abuse
- likely allergy or sensitivity to ACP-103, haloperidol, or risperidone, based on known allergies to drugs of the same class
- any subject who has participated in a prior clinical trial of ACP-103
- any subject judged by the Principal Investigator to be inappropriate for the study
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States11 sites
Study site
Austin, Texas, 78756
Study site
Cerritos, California, 90703
Study site
Garden Grove, California, 92845
Study site
Glendale, California, 91206
Study site
Irving, Texas, 75062
Study site
Paramount, California, 90723
Study site
Pico Rivera, California, 90660
Study site
San Diego, California, 92123
Study site
San Diego, California, 92126
Study site
St Louis, Missouri, 63118
Study site
Washington D.C., District of Columbia, 20016
Brazil6 sites
Study site
Aparecida de Goiânia, Goiás, 74922-810
Study site
Curitiba, Paraná, 80430-050
Study site
Curitiba, Paraná, 80520-000
Study site
Rio de Janeiro, Rio de Janeiro, 21020-130
Study site
Salvador, Estado de Bahia, 40325-090
Study site
São Paulo, São Paulo, 05403-010
About this study
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
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.
- Conditions
- Schizophrenia
- Being tested
- ACP-103
- Keywords
- Schizophrenia, psychosis, delusions, hallucination
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Delusions, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-103Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score on the Positive and Negative Symptom Scale (PANSS).
Secondary outcomes (1)
Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startAug 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel van Kammen, MD, PhD, Study chair, ACADIA Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361166
- Sponsor's protocol ID
- ACP-103-008
- Status last verified
- Mar 2007
- First submitted
- 3 Aug 2006
- Last updated
- 22 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00361166
- Acronym / sponsor ID
- ACP-103-008
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, psychosis, delusions, hallucination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 7 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female subjects ages 18-65 diagnosed with schizophrenia
- experiencing an acute exacerbation of psychosis
- has had prior response to antipsychotic therapy within the previous 3 years
- female subjects must be of non-childbearing potential or must comply with double-barrier protection methods against conception
- ability of subject or caregiver or legally authorized representative to provide informed consent
Key exclusion criteria (10 listed)
- inability of the subject or caregiver or legally authorized representative to provide consent
- any female subject who is pregnant or breast feeding
- any subject with concurrent mental illness or disability
- any subject considered to be a danger to themselves or others
- recent use of certain antipsychotics or other medications that might interfere with this study's medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP-103 | Drug | – |
Primary outcome
Total score on the Positive and Negative Symptom Scale (PANSS).
1 secondary outcome
Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel van Kammen, MD, PhD study chair
ACADIA Pharmaceuticals Inc.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACP-103 in people with Schizophrenia, run by ACADIA Pharmaceuticals Inc. at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score on the Positive and Negative Symptom Scale (PANSS).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2007.