Long-acting Paliperidone Palmitate Injection and Olanzapine for Schizophrenia

A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia

A randomized trial of olanzapine and Long-acting paliperidone palmitate injection in the treatment of 100 treatment- naive first-episode patients with schizophrenia.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Paliperidone; Drug: Olanzapine

Detailed Description

OBJECTIVE: Investigator compared the efficiency, social function, cognitive function and side effect of olanzapine and Long-acting paliperidone palmitate injection in the treatment of first-episode drug-naive patients with schizophrenia.

METHODS:

1. Clinical Trial: This is a randomized trial in treatment-naive first-episode patients with schizophrenia. The study consists of a 1-week stabilization phase, followed by 12 weeks of treatment. The total trial duration is 13 weeks.
2. Assessment Procedures:

2.1. Primary Outcome Variable-psychopathology: Assessment instruments include the Positive and Negative Syndrome Scale (PANSS), the Assessment of Negative Symptoms (SANS) and the Clinical Global Impression (ICG). Patients are interviewed at screening, at week-4, at week-1, at baseline and at every two weeks, for a total of 12 ratings.

2.2. Cognitive tests: A comprehensive battery of tests encompassing the cognitive domains of executive function, attention, memory, perception, and general intellect is administered twice at baseline and at the end of 16-week treatment by a trained psychologist. Scoring follows standardized procedures. The Wisconsin Card Sorting Test (WCST) is administered as a measure of executive function. The N-back (0-3 back) test is administered as a measure of working memory. Logical Memory I and II, Verbal Paired Associates I and II, Visual Reproduction I and II and Digits Forward from the Wechsler Memory Scale-Revised (WMS-R) are administered as a tests of episodic memory. The Distractibility version of Gordon Continuous Performance Test (CPT)is administered as a test of attention. A four-subtest version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R), consisting of the Arithmetic, Similarities, Picture Completion, and Digit Symbol Substitution tests is administered to obtain an estimate of current Full- Scale Intelligence Quotient (FSIQ).

2.3. Social functioning: The Personal and Social Performance Scale (PSP) examines the four dimensions of social functioning: Socially useful activities including work and study, personal and social relationships, self-care, disturbing and aggressive behaviors.

2.4. Side Effects: Parkinsonism is rated with the Simpson-Angus Scale for extrapyramidal side effects (SAS). The Abnormal Involuntary Movement Scale (AIMS) is chosen to assess tardive dyskinesia (TD) severity. All of the AIMS and Simpson-Angus Rating Scales are administered by the same investigator, at screening, at week-4, at week-1, at baseline and at baseline and at every two weeks, for a total of 12 ratings.

2.5.Weight gain measurement: weight gain every week 2.6. Serum measurement: triglyceride, blood sugar，cholesterol，blood pressure

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100096
    • Beijing HuiLongGuan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of schizophrenia or schizophreniform disorder;
• Duration of symptoms not longer than 60 months;
• No prior treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days;
• Between 18 and 45 years of age; and
• Current psychotic symptoms of moderate severity.

Exclusion Criteria:

• A DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform;
• Documented disease of the central nervous system that can interfere with the trial assessments including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic, infection;
• Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension);
• A clinically significant ECG abnormality in the opinion of the investigator;
• Pregnant or breast-feeding female;
• Use of disallowed concomitant therapy;
• History of severe allergy or hypersensitivity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paliperidone; Drug: Paliperidone, 75-150mg/month, once a month, 12 weeks	Drug: Paliperidone; Paliperidone
Active Comparator: Olanzapine; Drug: Olanzapine, 20mg/day, twice a day, 12 weeks	Drug: Olanzapine; Olanzapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms assessed on PANSS.	Clinical symptoms	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical global impression assessed on CGI.	clinical severity	12 weeks
Cognitive functioning assessed on RBANS.	cognitive performance	12 weeks
Number of weight change in treatment assessed on Weight gain.	weight gain	12 weeks
Abnormal Involuntary Movement Scale assessed Abnormal Involuntary Movement Scale assessed on AIMS.	Side effects	12 weeks

Collaborators and Investigators

• Sponsor: Beijing HuiLongGuan Hospital
• Investigators: Principal Investigator: Xiang Zhang, MD, PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Kim E, Correll CU, Mao L, Starr HL, Alphs L. Once-monthly paliperidone palmitate compared with conventional and atypical daily oral antipsychotic treatment in patients with schizophrenia. CNS Spectr. 2016 Dec;21(6):466-477. doi: 10.1017/S1092852916000444. Epub 2016 Sep 15.
• Yoshimura R, Hori H, Katsuki A, Atake K. Marked Improvement of Meige Syndrome in a Japanese Male Patient with Schizophrenia After Switching from Risperidone to Paliperidone: A Case Report. J UOEH. 2016 Sep;38(3):233-6. doi: 10.7888/juoeh.38.233.
• Young-Xu Y, Duh MS, Muser E, DerSarkissian M, Faust E, Kageleiry A, Bhak RH, Fu DJ, Lefebvre P, Shiner B. Impact of Paliperidone Palmitate Versus Oral Atypical Antipsychotics on Health Care Resource Use and Costs in Veterans with Schizophrenia. J Clin Psychiatry. 2016 Oct;77(10):e1332-e1341. doi: 10.4088/JCP.16m10745.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimate): September 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: schizophrenia; olanzapine; paliperidone; clinical trial
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Olanzapine; Paliperidone Palmitate
• Other Study ID Numbers: WZKN-sch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be available on request