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A randomized, controlled, multi-center clinical trial to study the treatment resistant schizophrenia (TRS) in Zhejiang province

A randomized, controlled, multi-center clinical trial to study the treatment resistant schizophrenia (TRS) in Zhejiang province

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004854
Enrollment
Unknown
Registered
2014-06-26
Start date
2014-07-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Sponsors

First Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Signed and dated informed consent document indicating that the patient is willing to participate in the trial and receive the treatment; 2. Female or male outpatients /inpatients, 18-45 years of age; 3. Meet the description of schizophrenia in the DSM-V; 4. There are still positive symptoms and the social functions having not recovered to the status before disease onset despite treatment with adequate doses and duration of 2 antipsychotics (6w) within 5 years; 5. BPRS>45, and PANSS>60;6. Be able to understand and follow the investigators requirements in the investigators opinion.

Exclusion criteria

Exclusion criteria: 1. Poor efficacy achieved in the previous treatment with adequate doses of Clozapine, Paliperidone and Olanzapine, or allergy to Paliperidone and Olanzapine; 2. Alcohol or drug dependence; 3. On electric shock treatment in recent 3 months; 4. Suicidal tendency (including suicide idea); 5. Patients with epilepsy or acute cerebrovascular diseases; 6. Patients with severe physical diseases of the nervous system, heart, liver, kidney, endocrine system and blood system, etc., or other disease may interfere with the assessment of the clinical trial; 7. Patients with organic mental disorders or mental retardation; 8. Women who are pregnant or breastfeeding, or women of childbearing potential who are about to get pregnant; 9. Neutrophil absolute count <1.5 x 109/L in the screening; 10. QTC interval =500ms, or other significant ECG events with clinical significance according to the investigator’s opinion; 11. Patients with other conditions that investigator considers ineligible for the trial.

Design outcomes

Primary

MeasureTime frame
PANSS;

Secondary

MeasureTime frame
PSP;BPRS;CGI;cognitive function;

Contacts

Public ContactHu Shaohua

First Affiliated Hospital, Zhejiang University School of Medicine

dorhushaohua@zju.edu.cn+86 13957162903

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026