SchizophrenicsPhase 1/2NCT04754750
Differences in Schizophrenia With One-month and 3-month Paliperidone Palmitate Treatment
A Phase 1/2 study testing Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega] and Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA] in people with Schizophrenics, run by Calo Psychiatric Center.
Trial summary
Schizophrenia is a chronic and severe psychiatric disorder, these patients suffer from positive symptoms, negative symptoms and cognitive deficits, of which working memory problems are considered a central cognitive impairment. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Schizophrenics
- What is being tested?
- Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega] and Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2017
- Phase
- Phase 1/2
- 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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of them had to meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
Who cannot join
- Patients who had comorbid serious medical illnesses, and may therefore present substantial clinical risk due to pharmacotherapy, were excluded from the sample, as were pregnant and lactating women.
About this study
Official title: Differences in Lipid and Cognitive Change Between One-month and 3-month Paliperidone Palmitate Treatment in Stable Schizophrenia
Schizophrenia is a chronic and severe psychiatric disorder, these patients suffer from positive symptoms, negative symptoms and cognitive deficits, of which working memory problems are considered a central cognitive impairment. Atypical antipsychotics are believed to have a superior effect in reducing both positive and negative symptoms of schizophrenia, coupled with a low risk of extrapyramidal symptoms. Particularly, 2nd-generation antipsychotic medications are commonly used in treatment of schizophrenia. An antipsychotic drug, Paliperidone palmitate (PDP), is administered to patients with schizophrenia as injections at one-month (PP1M) or three-month (PP3M) intervals. This study was compare the effects of treatment, social function, and side effects between PP1M and PP3M in patients with schizophrenia. Moreover, the changes of cognitive and lipid profile between two PDP were also explored. Firstly, participants were received the one month long-acting injection (PP1M) three months. Then, the stable participants were shifted to the three month long-acting injection (PP3M). Concomitant medications were allowed to prescribe except other antipsychotics. Outcome measurements were 20-item Toronto Alexithymia Scale (TAS-20), 45-itme quality of life for mental disorder (QOLMD), Short-version of the Udvalg for Kliniske Undersogelser (short-version UKU), and Wisconsin Card Sorting test (WCST). These measurements were performed every three-month except WCST which was performed every six-month. The different effects of PP1M and PP3M will be expected to find out in this study.
Read the detailed description
This is a two and half-one years, single-arm, nonrandomized, open-label study which was conducted between Jan 2015 to Jun 2017 including from a psychiatric center in southern Taiwan. The stable schizophrenic patients who previously received risperidone long-acting injection for more than one year and shifted to paliperidone palmitate after including in the study. Firstly, participants were received the one month long-acting injection (PP1M) three months. Then, the stable participants were shifted to the three month long-acting injection (PP3M). Concomitant medications were allowed to prescribe except other antipsychotics. Outcome measurements were 20-item Toronto Alexithymia Scale (TAS-20), 45-itme quality of life for mental disorder (QOLMD), Short-version of the Udvalg for Kliniske Undersogelser (short-version UKU), and Wisconsin Card Sorting test (WCST). These measurements were performed every three-month except WCST which was performed every six-month. The effect of treatment was assessed using Personal and Social Performance (PSP) scales for the evaluation of psychosocial functioning at 0, 4, 8, and 12 weeks in first study, and at 0, 3, 6, 9, 12 months in second study, respectively. In addition, all participants were assessed for body weight, waist circumference, and blood lipid profile. To evaluate the lipid profiles, fasting blood samples were analyzed for total cholesterol (TC), Triglyceride (TG), High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL). These blood samples were collected at every month until study completion.
- Conditions
- Schizophrenics
- Being tested
- Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega], Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]
- Keywords
- paliperidone palmitate, social function, cognitive function, quality of life
- Medical subject headings
- Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega]Drug
Also called Sustenna
Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]Drug
Also called Trinza
| Study group | Role | What they receive |
|---|---|---|
| INVEGA Sustenna | Active comparator | INVEGA Sustenna is a one month long-acting injection (PP1M) Receives: Drug: Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega] |
| INVEGA Trinza | Active comparator | INVEGA Trinza is a three month long-acting injection (PP3M) Receives: Drug: Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal and Social Performance scales (PSP)
Personal and Social Performance scales was assessed for the evaluation of psychosocial functioning. A higher score represents better psychosocial functioning.
Measured: 15 months
Short-version of the Udvalg for Kliniske Undersogelser (short-version UKU)
The Short-version of the Udvalg for Kliniske Undersogelser was assessed for the evaluation of psychic side effect. A higher score present to a mild or severe degree symptoms.
Measured: 15 months
Wisconsin Card Sorting test (WCST)
Wisconsin Card Sorting Test was assessed for the performance of cognitive function. A higher score in conceptual level response and lower score in percent of perseverative errors present to greater cognitive function.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study startJan 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophrenicsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Total of 72 participants, including 41 men and 31 female, were received the PP1M three months. The stable participants were shifted to PP3M for one year.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calo Psychiatric Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, For-Wey Lung, Calo Psychiatric Center
- Investigators
- For-Wey Lung, MD, ScD, Principal investigator, Calo Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754750
- Sponsor's protocol ID
- 100-046
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Lipid and Cognitive Change Between One-month and 3-month Paliperidone Palmitate Treatment in Stable Schizophrenia
- ClinicalTrials.gov ID
- NCT04754750
- Acronym / sponsor ID
- 100-046
- Conditions
- Schizophrenics
- Keywords
- paliperidone palmitate, social function, cognitive function, quality of life
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Calo Psychiatric CenterUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Feb 2021 (actual)
- 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.
Schizophrenia is a chronic and severe psychiatric disorder, these patients suffer from positive symptoms, negative symptoms and cognitive deficits, of which working memory problems are considered a central cognitive impairment. Atypical antipsychotics are believed to have a superior effect in reducing both positive and negative symptoms of schizophrenia, coupled with a low risk of extrapyramidal symptoms. Particularly, 2nd-generation antipsychotic medications are commonly used in treatment of schizophrenia. An antipsychotic drug, Paliperidone palmitate (PDP), is administered to patients with schizophrenia as injections at one-month (PP1M) or three-month (PP3M) intervals. This study was compare the effects of treatment, social function, and side effects between PP1M and PP3M in patients with schizophrenia. Moreover, the changes of cognitive and lipid profile between two PDP were also explored. Firstly, participants were received the one month long-acting injection (PP1M) three months. Then, the stable participants were shifted to the three month long-acting injection (PP3M). Concomitant medications were allowed to prescribe except other antipsychotics. Outcome measurements were 20-item Toronto Alexithymia Scale (TAS-20), 45-itme quality of life for mental disorder (QOLMD), Short-version of the Udvalg for Kliniske Undersogelser (short-version UKU), and Wisconsin Card Sorting test (WCST). These measurements were performed every three-month except WCST which was performed every six-month. The different effects of PP1M and PP3M will be expected to find out in this study.
Detailed description
This is a two and half-one years, single-arm, nonrandomized, open-label study which was conducted between Jan 2015 to Jun 2017 including from a psychiatric center in southern Taiwan. The stable schizophrenic patients who previously received risperidone long-acting injection for more than one year and shifted to paliperidone palmitate after including in the study. Firstly, participants were received the one month long-acting injection (PP1M) three months. Then, the stable participants were shifted to the three month long-acting injection (PP3M). Concomitant medications were allowed to prescribe except other antipsychotics. Outcome measurements were 20-item Toronto Alexithymia Scale (TAS-20), 45-itme quality of life for mental disorder (QOLMD), Short-version of the Udvalg for Kliniske Undersogelser (short-version UKU), and Wisconsin Card Sorting test (WCST). These measurements were performed every three-month except WCST which was performed every six-month. The effect of treatment was assessed using Personal and Social Performance (PSP) scales for the evaluation of psychosocial functioning at 0, 4, 8, and 12 weeks in first study, and at 0, 3, 6, 9, 12 months in second study, respectively. In addition, all participants were assessed for body weight, waist circumference, and blood lipid profile. To evaluate the lipid profiles, fasting blood samples were analyzed for total cholesterol (TC), Triglyceride (TG), High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL). These blood samples were collected at every month until study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Total of 72 participants, including 41 men and 31 female, were received the PP1M three months. The stable participants were shifted to PP3M for one year.
| Arm | Type | Receives |
|---|---|---|
| INVEGA Sustenna | Active comparator | Drug: Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega]INVEGA Sustenna is a one month long-acting injection (PP1M) |
| INVEGA Trinza | Active comparator | Drug: Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]INVEGA Trinza is a three month long-acting injection (PP3M) |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All of them had to meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
Key exclusion criteria (1 listed)
- Patients who had comorbid serious medical illnesses, and may therefore present substantial clinical risk due to pharmacotherapy, were excluded from the sample, as were pregnant and lactating women.
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 |
|---|---|---|
| Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega]Also: Sustenna | Drug | INVEGA Sustenna |
| Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]Also: Trinza | Drug | INVEGA Trinza |
Primary outcome
Personal and Social Performance scales (PSP)
Time frame: 15 months
Personal and Social Performance scales was assessed for the evaluation of psychosocial functioning. A higher score represents better psychosocial functioning.
Short-version of the Udvalg for Kliniske Undersogelser (short-version UKU)
Time frame: 15 months
The Short-version of the Udvalg for Kliniske Undersogelser was assessed for the evaluation of psychic side effect. A higher score present to a mild or severe degree symptoms.
Wisconsin Card Sorting test (WCST)
Time frame: 15 months
Wisconsin Card Sorting Test was assessed for the performance of cognitive function. A higher score in conceptual level response and lower score in percent of perseverative errors present to greater cognitive function.
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 15 Feb 2021.
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.
For-Wey Lung, MD, ScD principal investigator
Calo Psychiatric Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega] and Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA] in people with Schizophrenics, run by Calo Psychiatric Center.
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 1 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 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Personal and Social Performance scales (PSP) (time frame: 15 months). 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 15 Feb 2021.