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A 16-Week, Randomized, Open label, Haloperidol-Controlled Study to Evaluate the Efficacy of Ziprasidone in Improving Social Cognitive Function of Patients with Schizophrenia

A 16-Week, Randomized, Open label, Haloperidol-Controlled Study to Evaluate the Efficacy of Ziprasidone in Improving Social Cognitive Function of Patients with Schizophrenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060542
Enrollment
Unknown
Registered
2022-06-04
Start date
2009-10-01
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Schizophrenia

Interventions

Group 1:Ziprasidone treatment
Group 2:Haloperidol treatment

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 from 18-45 (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); 5. Able to understand and comply with the requirements of the study; 6. A score of items in PANSS (conceptual disorganization, suspiciousness, hallucinatory behaviour, unusual thought content) not more than 3; 7. A score of CGI-S not more than 4; 8. Psychiatry history not more than 10 years; 9. No antipsychotic medication in the month prior to treatment; 10. No electroconvulsive therapy, transcranial magnetic stimulation (TMS), or psychological therapy was used for 3 months prior to treatment.

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 Ziprasidone (or haloperidol), as judged by the investigator; 5. Use of any of t Potent cytochrome P450 1A2 inhibitors (including but not limited to fluvoxamine ciprofloxacin); 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-V criteria; 9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-V 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 28days 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 randomization of treatment in the present study; 15. Participation in another drug trial within 4 weeks prior to enrolment into this study or longer in accordance with local requirements; 16. Patient of schizophrenia catatonic type; Patient IQ =440ms 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 9, 2026