A randomised placebo controlled trial of intensive psychosocial treatment plus or minus anti-psychotic medication for first episode psychosis with low-risk of self-harm or aggression. The STAGES Study: Staged Treatment and Acceptability Guidelines in Early Psychosis

Not Applicable

Completed

• Conditions: First episode psychosis; Mental Health - Psychosis and personality disorders

• Registration Number: ACTRN12607000608460
• Lead Sponsor: Orygen

Brief Summary

This study examined whether antipsychotic medication is essential in the treatment of first episode psychosis or whether in some cases, psychological treatment can be sufficient. It was a randomised controlled non-inferiority trial that examined whether intensive psychosocial intervention for first episode psychosis in 15-25 year-olds was non-inferior to usual treatment of antipsychotic medication plus psychological treatment. This is a design that is used to assess whether a new treatment is at least as good (not inferior) as the current usual treatment. To maximise safety, participants were required to have low levels of suicidality and aggression, to have had psychosis for less than 6 months, and be living in stable accommodation with social support. The primary outcome was level of functioning at 6 months. Ninety young people were randomised by computer: 46 to placebo plus psychosocial treatment and 44 antipsychotic medication plus psychosocial treatment, and 33% of those who commenced trial medication completed the entire 6-month trial period. On the measure of functioning, both groups improved, and there were no differences between the groups on any symptoms, suggesting that medication may not be required in early treatment for all. As the study had small numbers and carefully selected participants, further studies are needed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-28
• Study Completion: 2019-07-31
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Ability to give informed consent (Capacity to give informed consent will be assessed by an Orygen Youth Health doctor in cases where an intellectual disability is suspected)
• Adequate comprehension of English to enable study assessments to be conducted
• Low suicidality (as defined by a score of < 5 on the exBPRS Suicidality subscale, i.e., no more than occasional suicidal thoughts with no plan or intent)
• Low aggressiveness (as defined by a score of < 5 on the exBPRS Hostility scale, i.e., may have been angry or yelled on several occasions but has not threatened people or thrown objects)
• Currently living in stable accommodation, in regular contact with people who support the young person's participation in the study.

Exclusion Criteria

- more than 7 days treatment with neuroleptic medication for the current psychotic episode
- A lifetime maximum dose of antipsychotic medication greater than an equivalent to 1750mg of chlorpromazine
- duration of untreated psychosis for longer than 6 months
- current pregnancy
- previous treatment with lithium or anticonvulsant medication for manic episode

Study & Design

• Study Type: Interventional
• Study Design: Not specified