Long-acting Paliperidone Palmitate Injection and Olanzapine for Schizophrenia

Sponsor

Beijing HuiLongGuan Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02918825

Collaborator

(none)

100

Enrollment

Location

Arms

12.9

Actual Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Olanzapine Drug: Paliperidone	N/A

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:

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.
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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Aug 30, 2017

Actual Study Completion Date :

Sep 30, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Symptoms assessed on PANSS. [12 weeks]
Clinical symptoms

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.