ACTRN12605000556640
Completed
Phase 3
Randomised controlled clinical trial of the efficacy and tolerability of Seroquel compared to Risperidone in the treatment of psychotic disorders among 15-18 year old adolescents.
Dr Harith Swadi0 sites60 target enrollmentSeptember 29, 2005
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr Harith Swadi
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of written informed consent. Young people under the age of 19 years admitted to the Youth Inpatient Unit YIU) with a psychotic disorder according to DSM\-IV criteria.Subjects must have a chronic or intermittent psychosis with a documented clinical diagnosis of: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Major Depressive Disorder with psychotic features, or Bipolar I Disorder according to the criteria of DSM IV \[18].
Exclusion Criteria
- •Patients with alcohol or substance dependence not in full remission. Previous and successful treatment with Quetiapine or Risperidone.History of non\-response to atypicals.Patients who have taken Clozapine within the previous 60 days.A positive test for pregnancy.Sexually active females who are not on a medically validated contraceptive e.g. double barrier, oral contraceptives, DepoProvera.Any clinical significant medical condition that could affect required evaluation or increase the risk of adverse affects with treatment.
Outcomes
Primary Outcomes
Not specified
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