Working… Menu

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. Identifier: NCT00334035
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : February 18, 2011
Information provided by:
The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Quetiapine Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Duration of Maintenance Anti-psychotic Therapy After First -Episode Schizophrenia: a Double-blind Randomized Placebo-control Relapse Prevention Study
Study Start Date : August 2003
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00334035

Layout table for location information
Hong Kong
Research Site
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Layout table for investigator information
Principal Investigator: Eric YH Chen, MD The University of Hong Kong

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00334035     History of Changes
Other Study ID Numbers: D1441C09906
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: June 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs