CompletedNot Applicable

Multicenter, Open-Label, Randomised, Haloperidol-controlled Study to Evaluate Seroquel as Mono-Therapy in the Treatment of Agitated Symptoms in the Patients With Acute Episode of Schizophrenia

80 participantsStarted 2007-05

Plain-language summary

This study attempts to observe the efficacy (response time) and safety of the second-generation antipsychotic agent-quetiapine versus the first-generation antipsychotic agent-haloperidol, in treating acute schizophrenia episode and to evaluate the effect of the effectiveness of acute schizophrenia episode on long-term tolerability.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent provided by legal guardians and/or patients.
. Age from 18-60 years old (inclusion), male or female, inpatients or outpatients.
. A diagnosis of schizophrenia by ICD-10 criteria as F20.0, F20.1, F20.2 and F20.3.
. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
. Able to understand and comply with the requirements of the study.
. PANSS total score at least 60 with EC factor score at least 15 at both screening and randomisation.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the onset of action quetiapine fumarate (seroquel) in the treatment of Chinese schizophrenic patient with agitation compared with haloperidol by the analysis of time to reduction of PANSS-EC by 20 %

Timeframe: 28 days

Trial details

NCT IDNCT00631722

SponsorPeking University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-01

View on ClinicalTrials.gov More Schizophrenia trials