342
Participants
Start Date
April 30, 2016
Primary Completion Date
July 31, 2019
Study Completion Date
May 31, 2022
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.
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.
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.
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.
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.
Headspace, Sunshine
Headspace, Werribee
Headspace, Glenroy
Orygen Youth Health Clinical Program, Melbourne
Headspace, Craigieburn
Lead Sponsor
National Institute of Mental Health (NIMH)
NIH
University of California, Davis
OTHER
University of California, San Francisco
OTHER
Orygen
OTHER