A Study to Evaluate the Efficacy and Safety of Seroquel in Chinese Han Patients With Schizophrenia

NCT00817648 | Completed Phase 4

• 2 other identifiers: D1443L00071SMHC-098
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this study is to evaluate the efficacy of seroquel in the treatment of patients with acute schizophrenia compared with risperidone by evaluating the change of PANSS total score from the baseline to week 6.

Conditions

Schizophrenia

Keywords

schizophrenia; antipsychotics; quetiapine; risperidone; efficacy; safety; multicenter; rater-blind; randomized; chinese; han

Outcome Measures

Primary Outcomes (1)

• the change of PANSS total score

  from the baseline to week 6

Secondary Outcomes (4)

• The Carlgary depression scale for schizophrenia (CDSS)

  from the baseline to week 6

• The abnormal involuntary movement scale (AIMS)

  from the baseline to Week 6

• The Simpson and Angus scale (SAS)

  from the baseline to week 6

• The clinical global impression (CGI),including CGI-I and CGI-S

  from the baseline to week 6

Study Arms (2)

1

EXPERIMENTAL

Quetiapine fumarate, flexible doses(600-750 mg/d)

Drug: Quetiapine

2

ACTIVE COMPARATOR

risperidone, flexible doses(3-6 mg/d)

Drug: risperidone

Interventions

Quetiapine DRUG

Quetiapine fumarate, 25mg/200 mg, the dose titration is carried in week 1. flexible doses(600-750 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator.

Also known as: Seroquel

1

risperidone DRUG

risperidone, 1mg/tablet, the dose titration is carried in week 1. flexible doses(3-6 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator.

Also known as: Risperdal

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent provided by legal guardians or patients.
• Patients who met DSM-IV criteria for schizophrenia: 295.20 (Schizophrenia, Catatonic Type), 295.10 (Schizophrenia, Disorganized Type), 295.30 (Schizophrenia, Paranoid Type), 295.60 (Schizophrenia, Residual Type), and 296.90 (Mood Disorder NOS).
• Age from 18-65 years old, male or female, Han nationality.
• PANSS total score at least 70 at baseline.
• 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. -

You may not qualify if:

• Pregnancy or lactation.
• Patients who have an imminent risk of suicide or a danger to self or others as judged by investigator.
• Known intolerance or lack of efficacy to seroquel and/or risperidone, as judged by the investigator.
• Use of seroquel and/or risperidone within 28 days prior to enrolment.
• 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.
• Use of a long acting antipsychotics Within one dosing interval
• Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse as defined by DSM-IV criteria within 28 days prior to enrolment.
• Medical conditions that would affect the 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.
• Participation in another drug trial within 28 days prior enrolment into this study.
• Patient with diabetes mellitus.
• The patient's absolute neutrophil count (ANC) ≤ 1.5 x 109/L and the ALT and AST values in the liver function test exceeding two times of the upper limits of normal values.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (4)

Mental Health Center of Luwan District

Shanghai, Shanghai Municipality, 200020, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Branch Hospital of Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 201108, China

Location

Huzhou Third People Hospital

Huzhou, Zhejiang, 313000, China

Location

Related Publications (5)

• Mandrioli R, Fanali S, Ferranti A, Raggi MA. HPLC analysis of the novel antipsychotic drug quetiapine in human plasma. J Pharm Biomed Anal. 2002 Nov 7;30(4):969-77. doi: 10.1016/s0731-7085(02)00395-3.

  PMID: 12408887 BACKGROUND

• Davis PC, Wong J, Gefvert O. Analysis and pharmacokinetics of quetiapine and two metabolites in human plasma using reversed-phase HPLC with ultraviolet and electrochemical detection. J Pharm Biomed Anal. 1999 Jun;20(1-2):271-82. doi: 10.1016/s0731-7085(99)00036-9.

  PMID: 10704032 BACKGROUND

• Riedel M, Muller N, Strassnig M, Spellmann I, Engel RR, Musil R, Dehning S, Douhet A, Schwarz MJ, Moller HJ. Quetiapine has equivalent efficacy and superior tolerability to risperidone in the treatment of schizophrenia with predominantly negative symptoms. Eur Arch Psychiatry Clin Neurosci. 2005 Dec;255(6):432-7. doi: 10.1007/s00406-005-0622-6. Epub 2005 Nov 4.

  PMID: 16267634 BACKGROUND

• Buckley PF. Efficacy of quetiapine for the treatment of schizophrenia: a combined analysis of three placebo-controlled trials. Curr Med Res Opin. 2004 Sep;20(9):1357-63. doi: 10.1185/030079904125004510.

  PMID: 15383183 BACKGROUND

• Miodownik C, Lerner V. Quetiapine: efficacy, tolerability and safety in schizophrenia. Expert Rev Neurother. 2006 Jul;6(7):983-92. doi: 10.1586/14737175.6.7.983.

  PMID: 16831113 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Quetiapine Fumarate; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Huafang LI, MD,PhD

  Drug Clinical Trial Office, Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 15, 2010

Record last verified: 2010-06

Locations

CN (4)