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

Schizophrenics Clinical Trial

Official title:

Differences in Lipid and Cognitive Change Between One-month and 3-month Paliperidone Palmitate Treatment in Stable Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754750
• Other study ID #: 100-046
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: February 2021
• Source: Calo Psychiatric Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenics

Intervention

Drug:
• Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega]

• Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Calo Psychiatric Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 months
Primary	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.	15 months
Primary	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.	15 months