SchizophreniaNCT02918825
Long-acting Paliperidone Palmitate Injection and Olanzapine for Schizophrenia
A study testing Olanzapine and Paliperidone in people with Schizophrenia, run by Beijing HuiLongGuan Hospital at 1 site in China.
Trial summary
A randomized trial of olanzapine and Long-acting paliperidone palmitate injection in the treatment of 100 treatment- naive first-episode patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine and Paliperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2016to 30 Sep 2017
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of schizophrenia or schizophreniform disorder;
- Duration of symptoms not longer than 60 months;
- No prior treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days;
- Between 18 and 45 years of age; and
- Current psychotic symptoms of moderate severity.
Who cannot join
- A DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform;
- Documented disease of the central nervous system that can interfere with the trial assessments including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic, infection;
- Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension);
- A clinically significant ECG abnormality in the opinion of the investigator;
- Pregnant or breast-feeding female;
- Use of disallowed concomitant therapy;
- History of severe allergy or hypersensitivity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia
A randomized trial of olanzapine and Long-acting paliperidone palmitate injection in the treatment of 100 treatment- naive first-episode patients with schizophrenia.
Read the detailed description
OBJECTIVE: Investigator compared the efficiency, social function, cognitive function and side effect of olanzapine and Long-acting paliperidone palmitate injection in the treatment of first-episode drug-naive patients with schizophrenia.
METHODS:
- Clinical Trial: This is a randomized trial in treatment-naive first-episode patients with schizophrenia. The study consists of a 1-week stabilization phase, followed by 12 weeks of treatment. The total trial duration is 13 weeks.
- Assessment Procedures:
2.1. Primary Outcome Variable-psychopathology: Assessment instruments include the Positive and Negative Syndrome Scale (PANSS), the Assessment of Negative Symptoms (SANS) and the Clinical Global Impression (ICG). Patients are interviewed at screening, at week-4, at week-1, at baseline and at every two weeks, for a total of 12 ratings.
2.2. Cognitive tests: A comprehensive battery of tests encompassing the cognitive domains of executive function, attention, memory, perception, and general intellect is administered twice at baseline and at the end of 16-week treatment by a trained psychologist. Scoring follows standardized procedures. The Wisconsin Card Sorting Test (WCST) is administered as a measure of executive function. The N-back (0-3 back) test is administered as a measure of working memory. Logical Memory I and II, Verbal Paired Associates I and II, Visual Reproduction I and II and Digits Forward from the Wechsler Memory Scale-Revised (WMS-R) are administered as a tests of episodic memory. The Distractibility version of Gordon Continuous Performance Test (CPT)is administered as a test of attention. A four-subtest version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R), consisting of the Arithmetic, Similarities, Picture Completion, and Digit Symbol Substitution tests is administered to obtain an estimate of current Full- Scale Intelligence Quotient (FSIQ).
2.3. Social functioning: The Personal and Social Performance Scale (PSP) examines the four dimensions of social functioning: Socially useful activities including work and study, personal and social relationships, self-care, disturbing and aggressive behaviors.
2.4. Side Effects: Parkinsonism is rated with the Simpson-Angus Scale for extrapyramidal side effects (SAS). The Abnormal Involuntary Movement Scale (AIMS) is chosen to assess tardive dyskinesia (TD) severity. All of the AIMS and Simpson-Angus Rating Scales are administered by the same investigator, at screening, at week-4, at week-1, at baseline and at baseline and at every two weeks, for a total of 12 ratings.
2.5.Weight gain measurement: weight gain every week 2.6. Serum measurement: triglyceride, blood sugar，cholesterol，blood pressure
- Conditions
- Schizophrenia
- Being tested
- Olanzapine, Paliperidone
- Keywords
- schizophrenia, clinical trial, olanzapine, paliperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Olanzapine
PaliperidoneDrug
Paliperidone
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone | Experimental | Drug: Paliperidone, 75-150mg/month, once a month, 12 weeks Receives: Drug: Paliperidone |
| Olanzapine | Active comparator | Drug: Olanzapine, 20mg/day, twice a day, 12 weeks Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms assessed on PANSS.
Clinical symptoms
Measured: 12 weeks
Secondary outcomes (4)
Clinical global impression assessed on CGI.
clinical severity
Measured: 12 weeks
Cognitive functioning assessed on RBANS.
cognitive performance
Measured: 12 weeks
Number of weight change in treatment assessed on Weight gain.
weight gain
Measured: 12 weeks
Abnormal Involuntary Movement Scale assessed Abnormal Involuntary Movement Scale assessed on AIMS.
Side effects
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion30 Aug 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 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
- Xiang Zhang, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918825
- Sponsor's protocol ID
- WZKN-sch
- Status last verified
- Jan 2018
- First submitted
- 20 Sep 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be available on request
Publications
Kim E, Correll CU, Mao L, Starr HL, Alphs L. Once-monthly paliperidone palmitate compared with conventional and atypical daily oral antipsychotic treatment in patients with schizophrenia. CNS Spectr. 2016 Dec;21(6):466-477. doi: 10.1017/S1092852916000444. Epub 2016 Sep 15.
PubMed 27629292Yoshimura R, Hori H, Katsuki A, Atake K. Marked Improvement of Meige Syndrome in a Japanese Male Patient with Schizophrenia After Switching from Risperidone to Paliperidone: A Case Report. J UOEH. 2016 Sep;38(3):233-6. doi: 10.7888/juoeh.38.233.
PubMed 27627971Young-Xu Y, Duh MS, Muser E, DerSarkissian M, Faust E, Kageleiry A, Bhak RH, Fu DJ, Lefebvre P, Shiner B. Impact of Paliperidone Palmitate Versus Oral Atypical Antipsychotics on Health Care Resource Use and Costs in Veterans with Schizophrenia. J Clin Psychiatry. 2016 Oct;77(10):e1332-e1341. doi: 10.4088/JCP.16m10745.
PubMed 27574835
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia
- ClinicalTrials.gov ID
- NCT02918825
- Acronym / sponsor ID
- WZKN-sch
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, clinical trial, olanzapine, paliperidone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beijing HuiLongGuan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 29 Sep 2016 (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.
A randomized trial of olanzapine and Long-acting paliperidone palmitate injection in the treatment of 100 treatment- naive first-episode patients with schizophrenia.
Detailed description
OBJECTIVE: Investigator compared the efficiency, social function, cognitive function and side effect of olanzapine and Long-acting paliperidone palmitate injection in the treatment of first-episode drug-naive patients with schizophrenia.
METHODS:
- Clinical Trial: This is a randomized trial in treatment-naive first-episode patients with schizophrenia. The study consists of a 1-week stabilization phase, followed by 12 weeks of treatment. The total trial duration is 13 weeks.
- Assessment Procedures:
2.1. Primary Outcome Variable-psychopathology: Assessment instruments include the Positive and Negative Syndrome Scale (PANSS), the Assessment of Negative Symptoms (SANS) and the Clinical Global Impression (ICG). Patients are interviewed at screening, at week-4, at week-1, at baseline and at every two weeks, for a total of 12 ratings.
2.2. Cognitive tests: A comprehensive battery of tests encompassing the cognitive domains of executive function, attention, memory, perception, and general intellect is administered twice at baseline and at the end of 16-week treatment by a trained psychologist. Scoring follows standardized procedures. The Wisconsin Card Sorting Test (WCST) is administered as a measure of executive function. The N-back (0-3 back) test is administered as a measure of working memory. Logical Memory I and II, Verbal Paired Associates I and II, Visual Reproduction I and II and Digits Forward from the Wechsler Memory Scale-Revised (WMS-R) are administered as a tests of episodic memory. The Distractibility version of Gordon Continuous Performance Test (CPT)is administered as a test of attention. A four-subtest version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R), consisting of the Arithmetic, Similarities, Picture Completion, and Digit Symbol Substitution tests is administered to obtain an estimate of current Full- Scale Intelligence Quotient (FSIQ).
2.3. Social functioning: The Personal and Social Performance Scale (PSP) examines the four dimensions of social functioning: Socially useful activities including work and study, personal and social relationships, self-care, disturbing and aggressive behaviors.
2.4. Side Effects: Parkinsonism is rated with the Simpson-Angus Scale for extrapyramidal side effects (SAS). The Abnormal Involuntary Movement Scale (AIMS) is chosen to assess tardive dyskinesia (TD) severity. All of the AIMS and Simpson-Angus Rating Scales are administered by the same investigator, at screening, at week-4, at week-1, at baseline and at baseline and at every two weeks, for a total of 12 ratings.
2.5.Weight gain measurement: weight gain every week 2.6. Serum measurement: triglyceride, blood sugar，cholesterol，blood pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paliperidone | Experimental | Drug: PaliperidoneDrug: Paliperidone, 75-150mg/month, once a month, 12 weeks |
| Olanzapine | Active comparator | Drug: OlanzapineDrug: Olanzapine, 20mg/day, twice a day, 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of schizophrenia or schizophreniform disorder;
- Duration of symptoms not longer than 60 months;
- No prior treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days;
- Between 18 and 45 years of age; and
- Current psychotic symptoms of moderate severity.
Key exclusion criteria (7 listed)
- A DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform;
- Documented disease of the central nervous system that can interfere with the trial assessments including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic, infection;
- Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension);
- A clinically significant ECG abnormality in the opinion of the investigator;
- Pregnant or breast-feeding female;
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 |
|---|---|---|
| OlanzapineOlanzapine | Drug | Olanzapine |
| PaliperidonePaliperidone | Drug | Paliperidone |
Primary outcome
Symptoms assessed on PANSS.
Time frame: 12 weeks
Clinical symptoms
4 secondary outcomes
Clinical global impression assessed on CGI.
Time frame: 12 weeks
Cognitive functioning assessed on RBANS.
Time frame: 12 weeks
Number of weight change in treatment assessed on Weight gain.
Time frame: 12 weeks
Abnormal Involuntary Movement Scale assessed Abnormal Involuntary Movement Scale assessed on AIMS.
Time frame: 12 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 18 Jan 2018.
- Results publication: PubMed 27629292Kim E, Correll CU, Mao L, Starr HL, Alphs L. Once-monthly paliperidone palmitate compared with conventional and atypical daily oral antipsychotic treatment in patients with schizophrenia. CNS Spectr. 2016 Dec;21(6):466-477. doi: 10.1017/S1092852916000444. Epub 2016 Sep 15.
- Results publication: PubMed 27627971Yoshimura R, Hori H, Katsuki A, Atake K. Marked Improvement of Meige Syndrome in a Japanese Male Patient with Schizophrenia After Switching from Risperidone to Paliperidone: A Case Report. J UOEH. 2016 Sep;38(3):233-6. doi: 10.7888/juoeh.38.233.
- Results publication: PubMed 27574835Young-Xu Y, Duh MS, Muser E, DerSarkissian M, Faust E, Kageleiry A, Bhak RH, Fu DJ, Lefebvre P, Shiner B. Impact of Paliperidone Palmitate Versus Oral Atypical Antipsychotics on Health Care Resource Use and Costs in Veterans with Schizophrenia. J Clin Psychiatry. 2016 Oct;77(10):e1332-e1341. doi: 10.4088/JCP.16m10745.
- Individual participant dataSharing planned: No. Data will be available on request
Related trials for Schizophrenia
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 recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
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
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.
Xiang Zhang, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olanzapine and Paliperidone 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 5 inclusion and 7 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 18 Jan 2018. 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?
Symptoms assessed on PANSS. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02918825, which also lists 3 linked publications.
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 18 Jan 2018.