Early Predictors of Poor Treatment Response in Patients With Schizophrenia Treated With Atypical Antipsychotics

NCT03730857 | Completed Phase 1

• 1 other identifier: T1-02
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: The aims of this study were to explore the relationship between early reduction in psychotic symptoms and the ultimate response in patients with schizophrenia treated by atypical antipsychotics, and to determine the best time to switch or maitain the regimen. PI also explore the possible predictors for the clinical response. Methods: One hundred eleven inpatients with acutely exacerbated schizophrenia were randomized to give optimal therapy of olanzapine, risperidone, and paliperidone in one-week run-in period and 12 weeks' intervention. All participants were assessed using Positive and Negative Syndrome Scale (PANSS). Early Response, defined as reduction of 25% in PANSS score, was examined at weeks 1, 2, 3, 4 and 8, and these ratings were used to predict ultimate response (25% PANSS reduction) at week 12. PI hypothesized that early treatment response at Week 1 or 2 could predict Week 12's treatment outcome.

Conditions

Schizophrenia

Keywords

schizophrenia; PANSS; positive predictive value; negative predictive value

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  The Positive and Negative Syndrome Scale (PANSS) rating scale was used to evaluate the changes of psychiatric symptoms in each time point. The raters in the present study had worked mainly on inpatient treatment of severe schizophrenic patients, and were well acquainted with symptoms of schizophrenia.

  12 weeks

Study Arms (3)

olanzapine

ACTIVE COMPARATOR

olanzapine has a dose of 10 to 20 mg daily for 12 weeks

Drug: Olanzapine

risperidone

ACTIVE COMPARATOR

risperidone at a dose of 4 to 6 mg daily for 12 weeks

Drug: risperidone

paliperidone

ACTIVE COMPARATOR

paliperidone at a dose of 6 to 12 mg daily for 12 weeks.

Drug: Paliperidone

Interventions

Olanzapine DRUG

olanzapine tablet

Also known as: second-generation antipsychotics

olanzapine

risperidone DRUG

risperidone tablet

Also known as: second-generation antipsychotics

risperidone

Paliperidone DRUG

paliperidone tablet

Also known as: second-generationantipsychotics

paliperidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) age 18 to 65 years,
• (2) no major systemic illnesses based on physical examinations and laboratory test results,
• (3) baseline PANSS total score≧60

You may not qualify if:

• (1) participants not taking any antipsychotics in the previous one month,
• (2) participants were pregnant and lactating women,
• (3) history of clozapine treatment in the previous 3 months,
• (4) patients receiving long-acting antipsychotic injections in the preceding 6 months of enrollment

Sponsors & Collaborators

• Calo Psychiatric Center: lead

Related Publications (1)

• Chen YL, Chen KP, Chiu CC, Tai MH, Lung FW. Early predictors of poor treatment response in patients with schizophrenia treated with atypical antipsychotics. BMC Psychiatry. 2018 Dec 4;18(1):376. doi: 10.1186/s12888-018-1950-1.

  PMID: 30509308 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine; Risperidone; 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; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Isoxazoles; Azoles

Study Officials

• For-Wey Lung, MD, ScD

  Calo Psychiatric Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Superintendent and Attending physician

Model Details: One hundred eleven inpatients with acutely exacerbated schizophrenia were randomized to give optimal therapy of olanzapine, risperidone, and paliperidone in one-week run-in period and 12 weeks' intervention.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 5, 2018
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 15, 2019

Record last verified: 2019-02