The Staged Treatment in Early Psychosis Study

Summary

A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a step-wise clinical approach for the treatment of ultra high risk patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes.

Conditions

• Psychotic Disorders
• Personality Disorders
• Clinical High Risk

Interventions

BEHAVIORAL

Support and Problem Solving Therapy

Support and Problem Solving Therapy involves providing participants with emotional support and helping them to resolve their problems in day-to-day life.

BEHAVIORAL

Cognitive Behavioural Case Management

CBCM has a number of different elements including: strategies to help with stress management; therapy that targets thinking and behavioural patterns; practical assistance, as well as yoga and mindfulness.

DRUG

Fluoxetine

Participants will commence on 1 capsule of fluoxetine 20 mg, to be taken in the morning. The medication can be increased to fluoxetine 40 mg daily if there has been a poor clinical response after the first 6 weeks of treatment.

DRUG

Placebo

Participants will commence on 1 capsule of the placebo pill, to be taken in the morning. The medication can be increased to 2 placebo capsules if there has been a poor clinical response after the first 6 weeks of treatment.

BEHAVIORAL

3-monthly monitoring

Study participants will be contacted on a 3-monthly basis by a study clinician who will be assessing the participant's risk.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of California, Davis

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Orygen

  lead OTHER

Principal Investigators

• Patrick McGorry, MD, PhD · Orygen Youth Research Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2019-07-31

Completion

2022-05-31

Countries

• Australia

Study Locations