Clinical trial NCT02918825: Long-acting Paliperidone Palmitate Injection and Olanzapine for Schizophrenia
Official title: A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
clinical trial
olanzapine
paliperidone
Lead sponsor: Beijing HuiLongGuan Hospital
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Symptoms assessed on PANSS.
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical global impression assessed on CGI.
timeFrame: 12 weeks
measure: Cognitive functioning assessed on RBANS.
timeFrame: 12 weeks
measure: Number of weight change in treatment assessed on Weight gain.
timeFrame: 12 weeks
measure: Abnormal Involuntary Movement Scale assessed Abnormal Involuntary Movement Scale assessed on AIMS.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Xiang Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.