Differences in Schizophrenia With One-month and 3-month Paliperidone Palmitate Treatment

February 12, 2021 updated by: For-Wey Lung, Calo Psychiatric Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: INVEGA Sustenna
INVEGA Sustenna is a one month long-acting injection (PP1M)
Drug: Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega]
Other Names:
  • Sustenna
Active Comparator: INVEGA Trinza
INVEGA Trinza is a three month long-acting injection (PP3M)
Drug: Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]
Other Names:
  • Trinza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 months
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.
15 months
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.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calo Psychiatric Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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