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

NCT00631722 | Completed

• 1 other identifier: D1443C00011
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Schizophrenia

Keywords

PANSS; Acute Episode of Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 %

  28 days

Secondary Outcomes (1)

• To evaluate the global efficacy of seroquel in the treatment of schizophrenia patient with agitation compared with haloperidol by evaluation of change of PANSS total score and CGI-S score from baseline to Week 4

  28 days

Study Arms (2)

A

EXPERIMENTAL

Drug: Quatiapine Fumarate

B

ACTIVE COMPARATOR

Drug: Haloperidol

Interventions

Quatiapine Fumarate DRUG

600-750mg/day

A

Haloperidol DRUG

12-20mg/day

B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent provided by legal guardians and/or patients.
• 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.

You may not qualify if:

• Pregnancy or lactation.
• Diagnosis of other mental disorders including mood disorder, schizoform disorder, schizoaffective disorder, delusional disorder, transient psychotic disorder etc.
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
• Known intolerance or lack of response to quetiapine fumarate and haloperidol, as judged by the investigator.
• Known lack of response to clozapine, as judged by the investigator.
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir.
• 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. John's Wort, and glucocorticoids.
• Within one dosing interval for long acting antipsychoticsUse.
• Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by ICD-10 criteria.
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by ICD-10 criteria within 28 days prior to enrolment.
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment.
• Unstable or inadequately treated medical illness (e.g. CHF - congestive heart failure, angina pectoris, hypertension) as judged by the investigator.
• Involvement in the planning and conduct of the study.
• Previous enrolment or randomisation of treatment in the present study.
• Participation in another drug trial within 28 days prior enrolment into this study or longer in accordance with local requirements.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Study Officials

• Tianmei Si, MD

  Mental Health Institute of Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: May 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 22, 2012

Record last verified: 2008-02