Second generation intervention research in the pre-psychotic phase of illness in schizophrenia and related psychoses

Prevention or delay of onset of psychosis in an 'ultra high risk' group: A comparison of risperidone and placebo in combination with intensive psychological treatment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000247673

Acronym

RIS-AUS-9

Enrollment

119

Registered

2005-08-31

Start date

2000-10-09

Completion date

2005-06-15

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

To investigate whether risperidone either alone or in combination with an intensive psychological treatment can delay or prevent the onset of an acute psychotic episode in young people thought to be at heightened risk of illness. The secondary aim was to investigate whether the interventions were effective in reducing general pscyhopathology in the participants whilst improving functioning.

Interventions

A comparison of the effectiveness of low-dose risperidone (0.5-2.0 mg/day) and intensive psychological treatment vs. placebo and intensive psychological treatment vs. placebo and a control psychological treatment in preventing or delaying the onset of psychosis in young people at risk of developing a psychotic illness: A 12-month blinded, placebo-controlled, parallel groups treatment period followed by a 12-month follow-up period.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

14 Years to 30 Years

Healthy volunteers

Inclusion criteria

Participants must meet 'ultra high risk' criteria as outlined in Yung, Phillips and McGorry (2004) Treating Schizophrenia in the Prodromal Phase. London: Taylor nd Francis. Also, have not previously experienced psychotic episode, IQ > 70, adequate English skills, and living in Melbourne metro area.

Exclusion criteria

No exclusion criteria

Outcome results