Long-acting Paliperidone Palmitate Injection and Olanzapine for Schizophrenia

• Status: Completed
• Trial end date: 2017-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beijing HuiLongGuan Hospital
• Collaborator: WenZhou-Kangning Hospital
• Treatments: Olanzapine; Paliperidone Palmitate

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.