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Long-acting Paliperidone Palmitate Injection and Olanzapine for Schizophrenia

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ClinicalTrials.gov Identifier: NCT02918825
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing HuiLongGuan Hospital

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 Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
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 : September 1, 2016
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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




Primary Outcome Measures :
  1. Symptoms assessed on PANSS. [ Time Frame: 12 weeks ]
    Clinical symptoms


Secondary Outcome Measures :
  1. Clinical global impression assessed on CGI. [ Time Frame: 12 weeks ]
    clinical severity

  2. Cognitive functioning assessed on RBANS. [ Time Frame: 12 weeks ]
    cognitive performance

  3. Number of weight change in treatment assessed on Weight gain. [ Time Frame: 12 weeks ]
    weight gain

  4. Abnormal Involuntary Movement Scale assessed Abnormal Involuntary Movement Scale assessed on AIMS. [ Time Frame: 12 weeks ]
    Side effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918825


Locations
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China
Beijing HuiLongGuan Hospital
Beijing, China, 100096
Sponsors and Collaborators
Beijing HuiLongGuan Hospital
Investigators
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Principal Investigator: Xiang Zhang, MD, PhD The University of Texas Health Science Center, Houston

Publications of Results:
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Responsible Party: Xiang Yang Zhang, Director of Biological psychiatry center,, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier: NCT02918825     History of Changes
Other Study ID Numbers: WZKN-sch
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available on request

Keywords provided by Xiang Yang Zhang, Beijing HuiLongGuan Hospital:
schizophrenia
clinical trial
olanzapine
paliperidone

Additional relevant MeSH terms:
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Paliperidone Palmitate
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents