Schizophrenia, CatatonicNCT00563017
Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone
A study testing Long-acting Risperidone microspheres injection in people with Schizophrenia, Catatonic and Schizophrenia, Disorganized, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Catatonic, Schizophrenia, Disorganized, Schizophrenia, Paranoid
- What is being tested?
- Long-acting Risperidone microspheres injection
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2004to Nov 2005
- Phase
- Interventional
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Subjects with schizophrenia or another psychotic disorder according to DSM IV criteria who requires long term antipsychotic therapy
- Currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic
- Subject has been symptomatically stable on a stable dose of an antipsychotic the last month
- Subject and/or patient's relative, guardian or legal representative has signed the informed consent form
Who cannot join
- First antipsychotic treatment ever
- On clozapine during the last 3 month
- Serious unstable medical condition
- History or current symptoms of tardive dyskinesia
- History of neuroleptic malignant syndrome
- Pregnant or breast-feeding female
Show all 9Show fewer
- Female patient of childbearing potential without adequate contraception.
- Participation in an investigational drug trial in the 30 days prior to selection
- Known intolerance/non-responder to risperidone
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Kwai Chung Hospital
Hong Kong
Gloria FY Chan, Dr
Ming-ming Chan, Dr
About this study
The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. Non-compliance is very common among schizophrenic and is a frequent cause of relapse.
- Conditions
- Schizophrenia, Catatonic, Schizophrenia, Disorganized, Schizophrenia, Paranoid, Schizophrenia, Psychotic Disorders
- Being tested
- Long-acting Risperidone microspheres injection
- Keywords
- Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Schizophrenia, Undifferentiated Schizophrenia, Schizo-affective disorders
- Medical subject headings
- Schizophrenia, Catatonic, Schizophrenia, Disorganized, Schizophrenia, Paranoid, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-acting Risperidone microspheres injectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy/ Clinical Global Impression
Measured: Week 0, 4, 8,12
Personal and Social Performance Scale
Measured: Week 0, 12
Extrapyramidal Symptom
Measured: Week 0, 4, 8,12
Secondary outcomes (2)
+Quality of life SF-36
Measured: Week 0,12
Pain assoicated with injection VAS
Measured: Week 0, 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startOct 2004
- Study completionNov 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia, CatatonicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Janssen Pharmaceutica N.V., Belgium
- Investigators
- Wing King Lee, Dr, Principal investigator, Yaumatei Psychiatric Center, Kwai Chung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563017
- Sponsor's protocol ID
- KW / EX / 04 - 038
- Other IDs
- HARECCTR0500047
- Status last verified
- Jul 2010
- First submitted
- 21 Nov 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone
- ClinicalTrials.gov ID
- NCT00563017
- Acronym / sponsor ID
- KW / EX / 04 - 038
- Conditions
- Schizophrenia, Catatonic, Schizophrenia, Disorganized, Schizophrenia, Paranoid, Schizophrenia, Psychotic Disorders
- Keywords
- Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Schizophrenia, Undifferentiated Schizophrenia, Schizo-affective disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Janssen Pharmaceutica N.V., Belgium
- Study start
- Oct 2004
- Study completion
- Nov 2005 (estimated)
- First posted
- 26 Nov 2007 (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 purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. Non-compliance is very common among schizophrenic and is a frequent cause of relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with schizophrenia or another psychotic disorder according to DSM IV criteria who requires long term antipsychotic therapy
- Currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic
- Subject has been symptomatically stable on a stable dose of an antipsychotic the last month
- Subject and/or patient's relative, guardian or legal representative has signed the informed consent form
Key exclusion criteria (9 listed)
- First antipsychotic treatment ever
- On clozapine during the last 3 month
- Serious unstable medical condition
- History or current symptoms of tardive dyskinesia
- History of neuroleptic malignant syndrome
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 |
|---|---|---|
| Long-acting Risperidone microspheres injection | Drug | – |
Primary outcome
Efficacy/ Clinical Global Impression
Time frame: Week 0, 4, 8,12
Personal and Social Performance Scale
Time frame: Week 0, 12
Extrapyramidal Symptom
Time frame: Week 0, 4, 8,12
2 secondary outcomes
+Quality of life SF-36
Time frame: Week 0,12
Pain assoicated with injection VAS
Time frame: Week 0, 4, 8, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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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.
Wing King Lee, Dr principal investigator
Yaumatei Psychiatric Center, Kwai Chung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-acting Risperidone microspheres injection in people with Schizophrenia, Catatonic and Schizophrenia, Disorganized, run by Hospital Authority, Hong Kong 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 9 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: status not confirmed, as of the sponsor's last update on 7 Jul 2010. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wing King Lee, Dr ((852) 2388 8559 ext. 269, drwklee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy/ Clinical Global Impression (time frame: Week 0, 4, 8,12). The study lists 3 primary outcomes in all. 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 7 Jul 2010.