SchizophreniaPhase 4NCT00305474
Identification and Treatment of the Liability to Develop Schizophrenia
A Phase 4 study testing Risperidone in people with Schizophrenia, run by Central South University at 1 site in China.
Trial summary
This study seeks to determine whether adult, non-psychotic, first-degree relatives of schizophrenic patients who show specific neurocognitive deficits and negative symptoms will show improvements in these areas following a 6-month, double-blind trial of a low dose (up to 2.0 mg) of risperidone. Read more about this study
- Who is it for?
- Ages 19 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2003to Jan 2010
- 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 19 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having at least one first-degree biological relative with schizophrenia and their age is between 19 and 59.
- Desire to participate in a medication trial.
- Is able to provide informed consent.
- Having moderate levels of negative symptoms, defined as 6 items rated 3 or higher on the Scale for the Assessment of Negative Symptoms (SANS).
- Scoring two or more standard deviations below normal in at least one of three cognitive domains: vigilance/working memory, long-term verbal memory, and executive functions.
- Scoring at least one standard deviation below normal in a second cognitive domain.
Who cannot join
- IQ less than 80.
- Formal education less than 10 years.
- History of psychotic disorders.
- History of treatment with an antipsychotic medication.
- A substance abuse diagnosis within 6 months of diagnosis.
- A head injury with documented loss of consciousness exceeding 5 minutes (or subsequent cognitive deficits).
Show all 9Show fewer
- A history of neurologic disease or damage.
- A medical condition with significant cognitive sequelae.
- A history of electroconvulsive treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mental Health Institute
Changsha, Hunan, 410011
Liwen Tan, MD, PhD, 01186-13874870034, gangbie7788@yahoo.com.cn
Liwen Tan, MD, PhD
About this study
This study seeks to determine whether adult, non-psychotic, first-degree relatives of schizophrenic patients who show specific neurocognitive deficits and negative symptoms will show improvements in these areas following a 6-month, double-blind trial of a low dose (up to 2.0 mg) of risperidone.
- Conditions
- Schizophrenia
- Being tested
- Risperidone
- Keywords
- Negative symptoms, neuropsychological deficits, Cognitive function, diagnostic, prevention
- Medical subject headings
- Schizophrenia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological - cognitive measures
Measured: 2003-2010
Secondary outcomes (1)
Psychiatric Symptoms
Measured: 2003-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startDec 2003
- Primary completionJan 2010 (estimated)
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Investigators
- William Stone, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)Lingjiang Li, MD, PhD, Study chair, Central South Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305474
- Sponsor's protocol ID
- XYMHI001
- Status last verified
- Jun 2009
- First submitted
- 21 Mar 2006
- Last updated
- 24 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Treatment of the Liability to Develop Schizophrenia
- ClinicalTrials.gov ID
- NCT00305474
- Acronym / sponsor ID
- XYMHI001
- Conditions
- Schizophrenia
- Keywords
- Negative symptoms, neuropsychological deficits, Cognitive function, diagnostic, prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Dec 2003
- Primary completion
- Jan 2010 (estimated)
- First posted
- 22 Mar 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.
This study seeks to determine whether adult, non-psychotic, first-degree relatives of schizophrenic patients who show specific neurocognitive deficits and negative symptoms will show improvements in these areas following a 6-month, double-blind trial of a low dose (up to 2.0 mg) of risperidone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Having at least one first-degree biological relative with schizophrenia and their age is between 19 and 59.
- Desire to participate in a medication trial.
- Is able to provide informed consent.
- Having moderate levels of negative symptoms, defined as 6 items rated 3 or higher on the Scale for the Assessment of Negative Symptoms (SANS).
- Scoring two or more standard deviations below normal in at least one of three cognitive domains: vigilance/working memory, long-term verbal memory, and executive functions.
Key exclusion criteria (9 listed)
- IQ less than 80.
- Formal education less than 10 years.
- History of psychotic disorders.
- History of treatment with an antipsychotic medication.
- A substance abuse diagnosis within 6 months of diagnosis.
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 |
|---|---|---|
| RisperidoneRisperidone will be given in low dosage to a random sample of family members of Schizophrenic patients | Drug | – |
Primary outcome
Neuropsychological - cognitive measures
Time frame: 2003-2010
1 secondary outcome
Psychiatric Symptoms
Time frame: 2003-2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 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.
William Stone, PhD principal investigator
Harvard Medical School (HMS and HSDM)
Lingjiang Li, MD, PhD study chair
Central South Unversity
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 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 6 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 24 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingjiang Li, MD, PhD (011-86-731-555-0413, lilj9016@public.cs.hn.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological - cognitive measures (time frame: 2003-2010). 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 24 Jun 2009.