Skip to content

An 24-Week, Randomized, Open-Label, Haloperidol-Controlled Study to Evaluate the Efficacy of Quetiapine in Improving Social Cognitive Function of Patients with Schizophrenia

An 24-Week, Randomized, Open-Label, Haloperidol-Controlled Study to Evaluate the Efficacy of Quetiapine in Improving Social Cognitive Function of Patients with Schizophrenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061843
Enrollment
Unknown
Registered
2022-07-03
Start date
2007-06-10
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Schizophrenia

Interventions

Group 1:treatment with quetiapine

Sponsors

Beijing Anding Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Provision of written informed consent by legal guardians; 2. Male or female, aged 18-45 years (inclusion); 3. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chronic gonadotropin (HCG) test at enrolment; 4. A diagnosis of schizophrenia by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV-TR); 5. Able to understand and comply with the requirements of the study; 6. Score of items in BPRS (conceptual disorganization, suspiciousness, hallucinatory behaviour, unusual thought content) not more than 3; 7. Score of CGI-S not more than 4; 8. Psychiatry history not more than 10 years.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation; 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria; 3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others; 4. Known intolerance or lack of response to paliperidone (or haloperidol), as judged by the investigator; 5. Use of any of t Potent cytochrome P450 1A2 inhibitors (including but not limited to fluvoxamineciprofloxacin); 6. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. Johns Wort, and glucocorticoids; 7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization; 8. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria; 9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment; 10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment; 11. Use of clozapine 28 days prior to study treatment; 12. A clinical finding that is unstable (e.g., diabetes mellitus CHF - congestive heart failure, angina pectoris, hypertension) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication; 13. Involvement in the planning and conduct of the study; 14. Previous enrolment or randomisation of treatment in the present study; 15. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements; 16. Patient of schizophrenia catatonic type; Patient IQ = 440 ms state; 18. Patients have been treated with FGA for more than 5 years.

Design outcomes

Primary

MeasureTime frame
first-order false belief test;second-order false belief test;faux pas test;reading the mind in the eyes test;Positive and Negative Syndrome Scale;

Countries

China

Contacts

Public ContactHongxiao Jia

Beijing Anding Hospital, Capital Medical University

jhxlj@vip.163.com+86 13661338687

Outcome results

None listed

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