Long-acting Paliperidone Palmitate Injection and Olanzapine for Schizophrenia

NCT02918825 | Completed DMC

• 1 other identifier: WZKN-sch
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

schizophrenia; clinical trial; olanzapine; paliperidone

Outcome Measures

Primary Outcomes (1)

• Symptoms assessed on PANSS.

  Clinical symptoms

  12 weeks

Secondary Outcomes (4)

• Clinical global impression assessed on CGI.

  12 weeks

• Cognitive functioning assessed on RBANS.

  12 weeks

• Number of weight change in treatment assessed on Weight gain.

  12 weeks

• Abnormal Involuntary Movement Scale assessed Abnormal Involuntary Movement Scale assessed on AIMS.

  12 weeks

Study Arms (2)

Paliperidone

EXPERIMENTAL

Drug: Paliperidone, 75-150mg/month, once a month, 12 weeks

Drug: Paliperidone

Olanzapine

ACTIVE COMPARATOR

Drug: Olanzapine, 20mg/day, twice a day, 12 weeks

Drug: Olanzapine

Interventions

Olanzapine DRUG

Olanzapine

Olanzapine

Paliperidone DRUG

Paliperidone

Paliperidone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing HuiLongGuan Hospital: lead

Study Sites (1)

Beijing HuiLongGuan Hospital

Beijing, 100096, China

Location

Related Publications (3)

• 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.

  PMID: 27629292 RESULT

• 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.

  PMID: 27627971 RESULT

• 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.

  PMID: 27574835 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine; Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Pyrimidines

Study Officials

• Xiang Zhang, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Biological psychiatry center,

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 29, 2016
• Study Start: September 1, 2016
• Primary Completion: August 30, 2017
• Study Completion: September 30, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)