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Antipsychotic Therapy and First Episode

This study has been completed.

Sponsors and Collaborators: AstraZeneca
Prof. Eric YH Chen, MD
University of Hong Kong
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00334035
  Purpose

For schizophrenic patients who remained in remission while on maintenance medication, there may come a point in time when the relative risk for relapse become so low that discontinuation of therapy can be considered. This study is to investigate whether that point in time is reached in 12 months following the first episode illness. Moreover, it also aims to identify other predictors of relapse as well as to evaluate the costs and benefits of maintenance therapy.


Condition Intervention Phase
Schizophrenia
Drug: Quetiapine
Phase IV

MedlinePlus related topics:   Schizophrenia   

ChemIDplus related topics:   Quetiapine    Quetiapine fumarate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Duration of Maintenance Anti-Psychotic Therapy After First -Episode Schizophrenia: a Double-Blind Randomized Placebo-Control Relapse Prevention Study

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • For patients in remission while on maintenance medication, the study investigates whether medication discontinuation can be reached in 12 months following a first episode illness.

Secondary Outcome Measures:
  • Predictors of relapse, and costs and benefits of maintenance therapy in terms of functioning, quality of life, side effects, carer's burden, negative symptoms and cognitive symptoms.

Enrollment:   169
Study Start Date:   August 2003
Study Completion Date:   June 2007

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Male or female patients, from 18 to 65 years of age at Visit 1
  • Patients must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
  • Patients must agree to cooperate with all tests and examinations required by the protocol. They must be willing to comply fully with treatment
  • Patient must understand the nature of the study and must sign an informed consent document.
  • Patients must be Cantonese speaking Han Chinese
  • Patients must be diagnosed, according to the SCID for DSM-IV, with schizophrenia, schizoaffective disorder or schizophreniform psychosis.
  • Patients must have good response to anti-psychotic treatment by achieving a rating of 2 or below in Clinical Global Impression Scale (CGI) Severity of illness; a rating of 4 or below in Improvement scale, and a rating of 3 or below in (conceptual disorganization, unusual thought content), a rating of 2 or below in (delusion, hallucinatory behavior) and a rating of 4 or below in (Suspiciousness) of Positive and Negative Syndrome Scale (PANSS) for at least 8 weeks

Exclusion Criteria:

  • Female patients who are either pregnant or lactating.
  • Patients previously on clozapine should be excluded from the study
  • Significant medical illnesses including seizures.
  • DSM-IV substance (alcohol or other drugs) abuse or dependence within the past 3 months.
  • Judged clinically to be at serious suicidal risk.
  • Treatment with an injectable depot neuroleptic within less than one of the patient's dosing intervals between depot neuroleptic injections prior to study entry.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334035

Locations
Hong Kong
Research Site    
      Hong Kong, Hong Kong

Sponsors and Collaborators
AstraZeneca
Prof. Eric YH Chen, MD
University of Hong Kong

Investigators
Principal Investigator:     Eric YH Chen, MD     University of Hong Kong    
  More Information


Study ID Numbers:   D1441C09906
First Received:   June 2, 2006
Last Updated:   June 30, 2008
ClinicalTrials.gov Identifier:   NCT00334035
Health Authority:   Hong Kong: Department of Health

Study placed in the following topic categories:
Schizophrenia
Quetiapine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008




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