Differences in Schizophrenia With One-month and 3-month Paliperidone Palmitate Treatment
Condition: Schizophrenics
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

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.
    

Intervention name(s): Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega]; Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]
Intervention type(s): Drug; Drug
Other intervention name(s): Sustenna; Trinza
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: paliperidone palmitate; social function; cognitive function; quality of life