SchizophreniaNCT02192723
A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia
A study testing Typical antipsychotic, Risperidone and Olanzapine in people with Schizophrenia, run by Beijing HuiLongGuan Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy and side effects of 6 commonly used antipsychotic drugs in the treatment of schizophrenia in a Chinese population. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Typical antipsychotic, Risperidone and Olanzapine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Jun 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients' diagnoses is based on the results of the Structured Clinical Interview for DSM (SCID) using the criteria of the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), physical exams and routine chemistry, and hematology laboratory tests. Attending-level psychiatrists will use a Chinese translation of the SCID to interview patients and their family members, who are given freedom to ask additional questions if respondents do not understand the standard probes.
- Patients must meet the following criteria: (1) diagnosis of schizophrenia; (2) duration of illness more than 2 years; (3) between 25 and 60 years of age; and (5) have NOT received antipsychotic medication for at least 1 month;(6) acute exacerbations of chronic inpatients.
- A complete medical history, electroencephalograms and electrocardiogram are obtained, and a physical examination and laboratory tests are performed at study entrance. None of the study participants have abnormal findings on these tests.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of 6 Antipsychotic Drugs in the Treatment of Acute Exacerbations of Chronic Inpatients With Schizophrenia: a Randomized Double-blind Study
The purpose of this study is to compare the efficacy and side effects of 6 commonly used antipsychotic drugs in the treatment of schizophrenia in a Chinese population.
Read the detailed description
The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared with that of older agents has been incompletely addressed, though newer agents are currently used far more commonly. The investigators compared a first-generation antipsychotic, perphenazine or haloperidol, with several newer drugs in a double-blind study.
METHODS: A total of 550 patients with schizophrenia were recruited at 4 Chinese sites and randomly assigned to receive perphenazine (16 to 64 mg per day) or haloperidol(6 t0 20mg per day), olanzapine (5 to 20 mg per day), quetiapine (400 to 750 mg per day), aripiprazole (10 to 30 mg per day) or risperidone (2 to 6.0 mg per day) for up to 8 weeks.
- Conditions
- Schizophrenia
- Being tested
- Typical antipsychotic, Risperidone, Olanzapine, Quetiapine, Aripiprazole
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typical antipsychoticDrug
Also called Haldol and Trilafon
Haloperidol (6~20mg/day) and perphenazine (16~64mg/day), twice per day, 8 weeks
RisperidoneDrug
Also called Risperdal
2~6mg/day, twice per day, 8 weeks
OlanzapineDrug
Also called Zyprexa
Olanzapine, 400~750mg/day, twice per day, 8 weeks
QuetiapineDrug
Also called Seroquel
Quetiapine, 400～750mg/day, twice per day, 8 weeks
AripiprazoleDevice
Also called Abilify
Aripiprazole, 10～30mg/day, twice per day, 8 weeks
ZiprasidoneDrug
Also called Geodon
Ziprasidone 80~160mg/day, twice per day, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Typical antipsychotic | Experimental | Haloperidol (6~20mg/day) and perphenazine (16~64mg/day) for 8 weeks. Receives: Drug: Typical antipsychotic |
| Risperidone | Active comparator | Risperidone, 2~6mg/day, twice day, 8 weeks Receives: Drug: Risperidone |
| Olanzapine | Active comparator | 5~20mg/day Receives: Drug: Olanzapine |
| Quetiapine | Active comparator | 400~750mg/day Receives: Drug: Quetiapine |
| Aripiprazole | Active comparator | Aripiprazole, 10~30mg/day, twice per day, 8 weeks Receives: Device: Aripiprazole |
| Ziprasidone | Active comparator | Ziprasidone, 80~160mg/day, twice per day, 8 weeks Receives: Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
Measured: Baseline, 8 weeks
Secondary outcomes (1)
Clinical Global Impression (CGI)
The Clinical Global Impression rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing HuiLongGuan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Yang Zhang, Beijing HuiLongGuan Hospital
- Investigators
- Zhi-Ren Wang, MD, PhD, Study director, Beijing HuiLongGuan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192723
- Sponsor's protocol ID
- Project863
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2014
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 6 Antipsychotic Drugs in the Treatment of Acute Exacerbations of Chronic Inpatients With Schizophrenia: a Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT02192723
- Acronym / sponsor ID
- Project863
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Beijing HuiLongGuan HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Jul 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.
The purpose of this study is to compare the efficacy and side effects of 6 commonly used antipsychotic drugs in the treatment of schizophrenia in a Chinese population.
Detailed description
The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared with that of older agents has been incompletely addressed, though newer agents are currently used far more commonly. The investigators compared a first-generation antipsychotic, perphenazine or haloperidol, with several newer drugs in a double-blind study.
METHODS: A total of 550 patients with schizophrenia were recruited at 4 Chinese sites and randomly assigned to receive perphenazine (16 to 64 mg per day) or haloperidol(6 t0 20mg per day), olanzapine (5 to 20 mg per day), quetiapine (400 to 750 mg per day), aripiprazole (10 to 30 mg per day) or risperidone (2 to 6.0 mg per day) for up to 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Typical antipsychotic | Experimental | Drug: Typical antipsychoticHaloperidol (6~20mg/day) and perphenazine (16~64mg/day) for 8 weeks. |
| Risperidone | Active comparator | Drug: RisperidoneRisperidone, 2~6mg/day, twice day, 8 weeks |
| Olanzapine | Active comparator | Drug: Olanzapine5~20mg/day |
| Quetiapine | Active comparator | Drug: Quetiapine400~750mg/day |
| Aripiprazole | Active comparator | Device: AripiprazoleAripiprazole, 10~30mg/day, twice per day, 8 weeks |
| Ziprasidone | Active comparator | Drug: ZiprasidoneZiprasidone, 80~160mg/day, twice per day, 8 weeks |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients' diagnoses is based on the results of the Structured Clinical Interview for DSM (SCID) using the criteria of the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), physical exams and routine chemistry, and hematology laboratory tests. Attending-level psychiatrists will use a Chinese translation of the SCID to interview patients and their family members, who are given freedom to ask additional questions if respondents do not understand the standard probes.
- Patients must meet the following criteria: (1) diagnosis of schizophrenia; (2) duration of illness more than 2 years; (3) between 25 and 60 years of age; and (5) have NOT received antipsychotic medication for at least 1 month;(6) acute exacerbations of chronic inpatients.
- A complete medical history, electroencephalograms and electrocardiogram are obtained, and a physical examination and laboratory tests are performed at study entrance. None of the study participants have abnormal findings on these tests.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Typical antipsychoticAlso: Haldol and TrilafonHaloperidol (6~20mg/day) and perphenazine (16~64mg/day), twice per day, 8 weeks | Drug | Typical antipsychotic |
| RisperidoneAlso: Risperdal2~6mg/day, twice per day, 8 weeks | Drug | Risperidone |
| OlanzapineAlso: ZyprexaOlanzapine, 400~750mg/day, twice per day, 8 weeks | Drug | Olanzapine |
| QuetiapineAlso: SeroquelQuetiapine, 400～750mg/day, twice per day, 8 weeks | Drug | Quetiapine |
| AripiprazoleAlso: AbilifyAripiprazole, 10～30mg/day, twice per day, 8 weeks | Device | Aripiprazole |
| ZiprasidoneAlso: GeodonZiprasidone 80~160mg/day, twice per day, 8 weeks | Drug | Ziprasidone |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, 8 weeks
1 secondary outcome
Clinical Global Impression (CGI)
Time frame: Baseline, 8 weeks
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 12 Jul 2016.
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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.
Zhi-Ren Wang, MD, PhD study director
Beijing HuiLongGuan 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 Typical antipsychotic, Risperidone and Olanzapine in people with Schizophrenia, run by Beijing HuiLongGuan Hospital 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 1 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 12 Jul 2016. 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?
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?
Positive and Negative Syndrome Scale (PANSS) (time frame: Baseline, 8 weeks). 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 12 Jul 2016.