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Antipsychotic Therapy and First Episode

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00334035
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:
The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE June 2, 2006
First Posted Date  ICMJE June 6, 2006
Last Update Posted Date February 18, 2011
Study Start Date  ICMJE August 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2006)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00334035 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2006)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antipsychotic Therapy and First Episode
Official Title  ICMJE Duration of Maintenance Anti-psychotic Therapy After First -Episode Schizophrenia: a Double-blind Randomized Placebo-control Relapse Prevention Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Quetiapine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2007)
169
Original Enrollment  ICMJE
 (submitted: June 2, 2006)
130
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00334035
Other Study ID Numbers  ICMJE D1441C09906
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric YH Chen, MD The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP