Antipsychotic Therapy and First Episode

Schizophrenia Clinical Trial

Official title:

Duration of Maintenance Anti-psychotic Therapy After First -Episode Schizophrenia: a Double-blind Randomized Placebo-control Relapse Prevention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334035
• Other study ID #: D1441C09906
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2006
• Last updated: February 17, 2011
• Start date: August 2003
• Est. completion date: June 2007

Study information

• Verified date: June 2008
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Quetiapine

Locations

Country	Name	City	State
Hong Kong	Research Site	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.