Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04754750 |
Other study ID # |
100-046 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 1/Phase 2
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.