SchizophreniaPhase 4NCT00859872
Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia
A Phase 4 study testing risperidone oral solution and haloperidol in people with Schizophrenia, run by Central South University at 1 site in China.
Trial summary
This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment sessions, parallel-group study. After screening period, eligible subjects will be entered 5 days treatment session I to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- risperidone oral solution and haloperidol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Mar 2009
- Phase
- Phase 4
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men or women aged 18 to 45 years
- DSM-IV diagnosis of acute exacerbation of schizophrenia or schizoaffective disorders
- A score of ≥ 14 on a 5-item acute-agitation cluster (including excitement, hostility, uncooperativeness and poor impulse control) derived from the PNASS
- The total scores ≥60 on the PANSS
Who cannot join
- Women who are pregnant or breast feeding, or who plan to become pregnant during the study
- The psychotic agitation is caused by delirium, epilepsy, mental retardation and affective disorder; intoxication or symptoms of withdrawal from alcohol or other psychoactive substances
- Clinical laboratory values indicating serious medical illness
- Known hypersensitivity to any of the study medications
- Treatment with a depot antipsychotic with 1 cycle of screening
- Using of disallowed medication
Trial locations and contacts
1 site in 1 country.
China1 site
MentalHealth Institute of the 2nd Xiangya Hospital, Central South University
Changsha, Hunan, 410011
About this study
Official title: Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol IM Injection for Treatment of Acute Psychotic Agitation in Schizophrenia
This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment sessions, parallel-group study.
After screening period, eligible subjects will be entered 5 days treatment session I to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation, then will be followed by 6 additional weeks treatment session II for exploring the effect of medicine switching from IM injection to oral.
Read the detailed description
Acute psychotic agitation is a common problem in many patients with schizophrenia that includes agitation, aggression, excitement and violence. An investigation showed that about 26% psychotic patients were brought to the psychiatric emergency room because of the psychotic agitation symptoms. The primary objective is to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation in patients of acute schizophrenia and schizophrenic-affective disorder.
The secondary objectives are: (1) to explore the possibility of decreasing efficacy of acute 6 weeks treatment from IM injection to oral; (2) to compare the safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection.
- Conditions
- Schizophrenia
- Being tested
- risperidone oral solution, haloperidol
- Keywords
- acute psychotic agitation, schizophrenia, risperidone oral solution, clonazepam, haloperidol
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidone oral solutionDrug
risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral
haloperidolDrug
haloperidol IM injection (5-20mg/d)
| Study group | Role | What they receive |
|---|---|---|
| oral group | Experimental | risperidone oral solution combination clonazepam oral Receives: Drug: risperidone oral solution |
| IM group | Active comparator | haloperidol IM injection Receives: Drug: haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of PANSS-EC scores
Measured: 5 days
Secondary outcomes (1)
response rate based on the PANSS
Measured: 47 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMar 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Mental Health Centre, Capital Medical University, Shanghai Mental Health Center, Guangzhou Mental Hospital, Chongqing Mental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859872
- Sponsor's protocol ID
- IIS-0801
- Status last verified
- Jul 2009
- First submitted
- 10 Mar 2009
- Last updated
- 3 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol IM Injection for Treatment of Acute Psychotic Agitation in Schizophrenia
- ClinicalTrials.gov ID
- NCT00859872
- Acronym / sponsor ID
- IIS-0801
- Conditions
- Schizophrenia
- Keywords
- acute psychotic agitation, schizophrenia, risperidone oral solution, clonazepam, haloperidol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- Wuhan Mental Health Centre, Capital Medical University, Shanghai Mental Health Center, Guangzhou Mental Hospital, Chongqing Mental Hospital
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Mar 2009 (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.
This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment sessions, parallel-group study.
After screening period, eligible subjects will be entered 5 days treatment session I to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation, then will be followed by 6 additional weeks treatment session II for exploring the effect of medicine switching from IM injection to oral.
Detailed description
Acute psychotic agitation is a common problem in many patients with schizophrenia that includes agitation, aggression, excitement and violence. An investigation showed that about 26% psychotic patients were brought to the psychiatric emergency room because of the psychotic agitation symptoms. The primary objective is to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation in patients of acute schizophrenia and schizophrenic-affective disorder.
The secondary objectives are: (1) to explore the possibility of decreasing efficacy of acute 6 weeks treatment from IM injection to oral; (2) to compare the safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral group | Experimental | Drug: risperidone oral solutionrisperidone oral solution combination clonazepam oral |
| IM group | Active comparator | Drug: haloperidolhaloperidol IM injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men or women aged 18 to 45 years
- DSM-IV diagnosis of acute exacerbation of schizophrenia or schizoaffective disorders
- A score of ≥ 14 on a 5-item acute-agitation cluster (including excitement, hostility, uncooperativeness and poor impulse control) derived from the PNASS
- The total scores ≥60 on the PANSS
Key exclusion criteria (6 listed)
- Women who are pregnant or breast feeding, or who plan to become pregnant during the study
- The psychotic agitation is caused by delirium, epilepsy, mental retardation and affective disorder; intoxication or symptoms of withdrawal from alcohol or other psychoactive substances
- Clinical laboratory values indicating serious medical illness
- Known hypersensitivity to any of the study medications
- Treatment with a depot antipsychotic with 1 cycle of screening
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 |
|---|---|---|
| risperidone oral solutionrisperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral | Drug | oral group |
| haloperidolhaloperidol IM injection (5-20mg/d) | Drug | IM group |
Primary outcome
the change of PANSS-EC scores
Time frame: 5 days
1 secondary outcome
response rate based on the PANSS
Time frame: 47 days
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 3 Aug 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing risperidone oral solution and haloperidol in people with Schizophrenia, run by Central South University at 1 site in China.
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 4 inclusion and 6 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 3 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the change of PANSS-EC scores (time frame: 5 days). 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 3 Aug 2009.