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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00334035 |
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Date of registration:
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02/06/2006 |
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Primary sponsor: |
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Public title:
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Antipsychotic Therapy and First Episode
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Scientific title:
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Duration of Maintenance Anti-psychotic Therapy After First -Episode Schizophrenia: a Double-blind Randomized Placebo-control Relapse Prevention Study |
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Date of first enrolment:
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August 2003 |
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Target sample size:
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169 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00334035 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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Countries of recruitment
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Hong Kong
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Contacts
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Name:
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Eric YH Chen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Hong Kong |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: Quetiapine
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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D1441C09906
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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