Psychotic DisordersNCT02137616
Antipsychotic to Treat Psychosis Syndrome
A study testing risperidone, olanzapine and Quetiapine in people with Psychotic Disorders, run by Central South University at 1 site in China.
Trial summary
This study assess the safety and effects of atypical antipsychotics in subjects with psychosis syndrome and psychosis risk syndrome. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- risperidone, olanzapine and Quetiapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2014
- 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 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- were help-seeking young individuals in outpatients service
- aged 16-30 years
- fitted one of the following Criteria: Psychosis-risk Syndromes (COPS-SIPS) or Psychotic Syndrome (POPS-SIPS) or DSM-IV diagnosis of schizophreniform disorder
Who cannot join
- a previous diagnosis of any psychotic disorder or bipolar disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition;
- symptoms fully accounted for by an Axis 1 disorder or sequelae of drug/alcohol use;
- neurological disorders or organic disorders affecting the central nervous system, substance-related disorders or mental retardation as defined by the DSM-IV criteria;
- history treatment of antipsychotic or antidepression, mood stabilizers or electroconvulsive therapy;
- diagnosed as having a serious and unstable medical condition.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Xiangya Hospital
Changsha, Hunan, 410011
Xiaofeng Guo, dr, 073185554052 ext. 073185554052, fengcsu@yahoo.com.cn
xiaofeng Guo, dr
About this study
Official title: Effectiveness of Antipsychotic Drugs to Treat Psychosis Syndrome: an Open Label, Controlled Study
This study assess the safety and effects of atypical antipsychotics in subjects with psychosis syndrome and psychosis risk syndrome.
Read the detailed description
The investigators investigated whether administration of atypical antipsychotics could alleviate prodromal symptoms and be well tolerated by subjects with psychosis syndrome and psychosis risk syndrome.
- Conditions
- Psychotic Disorders
- Being tested
- risperidone, olanzapine, Quetiapine, Aripiprazole
- Keywords
- psychosis, syndrome, risk, antipsychotic
- Medical subject headings
- Psychotic Disorders, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
Also called Risperidol
Risperdal tablets
olanzapineDrug
Also called olanzapine tablets
olanzapine tablets
QuetiapineDrug
Also called quetiapine tablets
quetiapine tablets
AripiprazoleDrug
Also called Aripiprazole tablets
Aripiprazole tablets
| Study group | Role | What they receive |
|---|---|---|
| risperidone | Active comparator | low dosage of antipsychotic drug Receives: Drug: risperidone |
| olanzapine | Active comparator | low doseage of antipsychotic Receives: Drug: olanzapine |
| quetiapine | Active comparator | low doseage of antipsychotic Receives: Drug: Quetiapine |
| aripiprazole | Active comparator | low doseage of antipsychotic Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of PANSS total scores from baseline to 18 months
Measured: 18 months
Secondary outcomes (2)
Social function
Social function was assessed by the Global Assessment of Functioning (GAF) every three month
Measured: 18 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Adverse Events were assessed at baseline and every month after treatments
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startJun 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaofeng Guo, Central South University
- Investigators
- xiaofeng Guo, Dr, Principal investigator, the second xiangya hospitcal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137616
- Sponsor's protocol ID
- 201002003
- Status last verified
- May 2014
- First submitted
- 5 May 2014
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Antipsychotic Drugs to Treat Psychosis Syndrome: an Open Label, Controlled Study
- ClinicalTrials.gov ID
- NCT02137616
- Acronym / sponsor ID
- 201002003
- Conditions
- Psychotic Disorders
- Keywords
- psychosis, syndrome, risk, antipsychotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 May 2014 (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 assess the safety and effects of atypical antipsychotics in subjects with psychosis syndrome and psychosis risk syndrome.
Detailed description
The investigators investigated whether administration of atypical antipsychotics could alleviate prodromal symptoms and be well tolerated by subjects with psychosis syndrome and psychosis risk syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| risperidone | Active comparator | Drug: risperidonelow dosage of antipsychotic drug |
| olanzapine | Active comparator | Drug: olanzapinelow doseage of antipsychotic |
| quetiapine | Active comparator | Drug: Quetiapinelow doseage of antipsychotic |
| aripiprazole | Active comparator | Drug: Aripiprazolelow doseage of antipsychotic |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- were help-seeking young individuals in outpatients service
- aged 16-30 years
- fitted one of the following Criteria: Psychosis-risk Syndromes (COPS-SIPS) or Psychotic Syndrome (POPS-SIPS) or DSM-IV diagnosis of schizophreniform disorder
Key exclusion criteria (5 listed)
- a previous diagnosis of any psychotic disorder or bipolar disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition;
- symptoms fully accounted for by an Axis 1 disorder or sequelae of drug/alcohol use;
- neurological disorders or organic disorders affecting the central nervous system, substance-related disorders or mental retardation as defined by the DSM-IV criteria;
- history treatment of antipsychotic or antidepression, mood stabilizers or electroconvulsive therapy;
- diagnosed as having a serious and unstable medical condition.
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 |
|---|---|---|
| risperidoneAlso: RisperidolRisperdal tablets | Drug | risperidone |
| olanzapineAlso: olanzapine tabletsolanzapine tablets | Drug | olanzapine |
| QuetiapineAlso: quetiapine tabletsquetiapine tablets | Drug | quetiapine |
| AripiprazoleAlso: Aripiprazole tabletsAripiprazole tablets | Drug | aripiprazole |
Primary outcome
Changes of PANSS total scores from baseline to 18 months
Time frame: 18 months
2 secondary outcomes
Social function
Time frame: 18 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
Related trials for Psychotic Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
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.
xiaofeng Guo, Dr principal investigator
the second xiangya hospitcal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing risperidone, olanzapine and Quetiapine in people with Psychotic Disorders, 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 3 inclusion and 5 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 14 May 2014. 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 xiaofeng Guo, Dr. (073185554052 ext. 073185554052, fengcsu@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of PANSS total scores from baseline to 18 months (time frame: 18 months). 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 14 May 2014.