5-HTR2A, DRD2,and COMT Genes Polymorphisms and Olanzapine Plasma Concentration in Treatment of Early-onset Schizophrenia

NCT02435654 | Completed Phase 4

• 1 other identifier: 81460218
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

In this study,investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7 years old and onset of illness before 17 years old, and all EOS patients will receive a 8-week systematic olanzepine titration treatment and a battery of assessments of treatment effect and safety. Blood olanzepine plasma concentration will be tested regularly and genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes genotyping technology. The aim of the study is to explore the predictive factors on olanzepine treatment response in EOS, which can guide the individualized treatment and improve the cure rate of EOS in clinical setting.

Conditions

Early-onset Schizophrenia

Keywords

Genes Polymorphisms; Plasma Concentration

Outcome Measures

Primary Outcomes (1)

• multiple regression equation of 5-HTR2A、DRD2 and COMT Genes Polymorphisms and Olanzapine Plasma Concentration and clinical features

  12 weeks

Secondary Outcomes (4)

• change in score of PANSS

  baseline and 12 weeks

• plateau concentration of olanzapine

  2 or 3,12 weeks

• change in Serum prolactin levels

  12 weeks

• Prevalence associated with age、gender and onset form

  12 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

All EOS patients will receive olanzapine treatment with flexible dose(2.5 to 20 mg/day)according to standard body weight,olanzapine will be initiated at 2.5 or 5 mg/day and the dose could be increased by 2.5 or 5 mg/day dose increments at the investigator's discretion.A effective dose would be titrated in two weeks with no tolerability or safety issues are apparent,the investigator could decrease the dose at any time and in any number of dose decrements if patients experienced an adverse event.

Drug: olanzapine

Interventions

olanzapine DRUG

olanzapine will be initiated at 2.5 or 5 mg/day according to patient's weight, and the dose could be increased by 2.5 or 5 mg every 4-7days at the investigator's discretion.A effective dose would be titrated in two weeks with no tolerability or safety issues are apparent,

Also known as: Zyprexa

Treatment group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• above 7 years old,
• age of onset ≤17 years old,
• Han or other nationality, male or female,
• in line with the diagnostic DSM-V criteria for schizophrenia, and
• negative and positive symptom scale (Positive and Negative Syndrome Scale, PANSS) score ≥70 points;
• patients are in the condition of first-episode, or relapse.

You may not qualify if:

• IQ \<70,
• current or previous history of traumatic brain injury,
• psychoactive substance use,
• personality disorders,
• obvious abnormalities on physical and laboratory examination,
• previous allergy or olanzapine had significant adverse reactions.

Sponsors & Collaborators

• Kunming Medical University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Psychiatry Department,First Affiliated Hospial Of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Interventions

Olanzapine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xu xiufeng

  Psychiatry Department ,First Affiliated Hospital Of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 6, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 2, 2021

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)