Seroquel compared to Risperidone in the treatment of psychotic disorders adolescents.

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000556640

Enrollment

Registered

2005-09-29

Start date

2003-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine if treatment with quetiapine will improve young patients psychosis.

Interventions

Quetiapine fumarate (titrate to between 400 and 800mg) Risperidone (titrated to between 4-6mg)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 19 Years

Healthy volunteers

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.

Outcome results