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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Si Tianmei, Peking University
ClinicalTrials.gov Identifier:
NCT00631722
First received: February 29, 2008
Last updated: August 21, 2012
Last verified: February 2008
  Purpose

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.


Condition Intervention
Schizophrenia
Drug: Quatiapine Fumarate
Drug: Haloperidol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • 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 % [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: May 2007
Study Completion Date: May 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Quatiapine Fumarate
600-750mg/day
Active Comparator: B Drug: Haloperidol
12-20mg/day

Detailed Description:

Both medication and patient can affect the compliance of patients to treatment. The control of schizophrenia syndromes effectively and rapidly will build up the confidence of patients on treatments. These early effects may influence the long-term compliance and prognosis of patients. And the antipsychotic medications with neuroprotection effect can significantly improve the long-term prognosis of patients, too.In the past, we always think that there is "delayed onset of antipsychotic" by antipsychotic medications. Recently, a large sample study indicated that the onset of antipsychotic effect was as early as the first day after administration (in 24 hours). This study was carried out in order to compare the second-generation antipsychotic agent- quetiapine with the first-generation antipsychotic agent- haloperidol on the onset time of treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent provided by legal guardians and/or patients.
  2. Age from 18-60 years old (inclusion), male or female, inpatients or outpatients.
  3. A diagnosis of schizophrenia by ICD-10 criteria as F20.0, F20.1, F20.2 and F20.3.
  4. 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.
  5. Able to understand and comply with the requirements of the study.
  6. PANSS total score at least 60 with EC factor score at least 15 at both screening and randomisation.

Exclusion Criteria:

  1. Pregnancy or lactation.
  2. Diagnosis of other mental disorders including mood disorder, schizoform disorder, schizoaffective disorder, delusional disorder, transient psychotic disorder etc.
  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 quetiapine fumarate and haloperidol, as judged by the investigator.
  5. Known lack of response to clozapine, as judged by the investigator.
  6. 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.
  7. 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.
  8. Within one dosing interval for long acting antipsychoticsUse.
  9. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by ICD-10 criteria.
  10. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by ICD-10 criteria within 28 days prior to enrolment.
  11. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment.
  12. Unstable or inadequately treated medical illness (e.g. CHF - congestive heart failure, angina pectoris, hypertension) as judged by the investigator.
  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 28 days prior enrolment into this study or longer in accordance with local requirements.
  16. Use of antipsychotics 2 days prior to study treatment
  17. Use of clozapine 28 days prior to study treatment.
  18. Use of ECT 1 months prior to screening.
  19. Initiate quetiapine or haloperidol treatment within 30 days prior to screening.
  20. Use of MAOI 14 days prior to study treatment
  21. The patient's complete blood count (CBC) with white blood cell (WBC) differential shows an neurotrophil count of ≤ 1.5 x 109/L at screening
  22. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

    • Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) >8.5%
    • Admitted to hospital for treatment of DM or DM related illness in past 12 weeks
    • Not under physician care for DM
    • Physician responsible for patient's DM care has not indicated that patient's DM is controlled
    • Physician responsible for patient's DM care has not approved patient's participation in the study
    • Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to allocation to treatment. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks
    • Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631722

Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Tianmei Si, MD Mental Health Institute of Peking University
  More Information

No publications provided

Responsible Party: Si Tianmei, Professor, Peking University
ClinicalTrials.gov Identifier: NCT00631722     History of Changes
Other Study ID Numbers: D1443C00011
Study First Received: February 29, 2008
Last Updated: August 21, 2012
Health Authority: China: Ethics Committee

Keywords provided by Peking University:
PANSS
Acute Episode of Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Haloperidol
Haloperidol decanoate
Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 23, 2014