The Staged Treatment in Early Psychosis Study

PHASE3CompletedINTERVENTIONAL
Enrollment

342

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

July 31, 2019

Study Completion Date

May 31, 2022

Conditions
Psychotic DisordersPersonality DisordersClinical 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.

Trial Locations (5)

3020

Headspace, Sunshine

3030

Headspace, Werribee

3046

Headspace, Glenroy

3052

Orygen Youth Health Clinical Program, Melbourne

3064

Headspace, Craigieburn

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

University of California, Davis

OTHER

collaborator

University of California, San Francisco

OTHER

lead

Orygen

OTHER

NCT02751632 - The Staged Treatment in Early Psychosis Study | Biotech Hunter | Biotech Hunter