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

NCT04754750 | Completed Phase 1 DMC

• 1 other identifier: 100-046
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Schizophrenics

Keywords

paliperidone palmitate; social function; cognitive function; quality of life

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

INVEGA Sustenna

ACTIVE COMPARATOR

INVEGA Sustenna is a one month long-acting injection (PP1M)

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

INVEGA Trinza

ACTIVE COMPARATOR

INVEGA Trinza is a three month long-acting injection (PP3M)

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

Interventions

Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega] DRUG

Also known as: Sustenna

INVEGA Sustenna

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

Also known as: Trinza

INVEGA Trinza

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Calo Psychiatric Center: lead

MeSH Terms

Conditions

Social Adjustment

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• For-Wey Lung, MD, ScD

  Calo Psychiatric Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 15, 2021
• Study Start: January 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 15, 2021

Record last verified: 2021-02