None listed
Conditions
Brief summary
Background Over the last decade, there has been a significant shift in psychiatric services towards a greater focus on early intervention for psychotic illnesses. This has raised the question of what the most appropriate form of treatment is for people (very) early in the course of a first psychotic episode. It is also possible that due to the efforts of early detection programs, the composition of first episode psychosis (FEP) cohorts may have changed towards including those who may have a more benign course of psychotic symptoms and thus may respond to more benign treatments. Aims The purpose of this project is to investigate whether a sub-group of young people can recover from FEP with intensive psychosocial intervention but without taking antipsychotic medication. Although we know that antipsychotic medication is usually helpful in assisting recovery from psychosis, medication may not be essential for effective treatment in all cases. Furthermore, there is also evidence that psychological treatment is helpful and may be sufficient and more acceptable to young people who are experiencing FEP. Design Participants will be young people, aged 15 - 25 receiving treatment from the Early Psychosis Prevention and Intervention Centre (EPPIC) of ORYGEN Youth Health. Approximately 95 young people will be randomised to two treatment groups: 1. Medication (risperidone) plus intensive psychosocial treatment (MIPT) 2. Placebo plus intensive psychosocial treatment (PIPT) The trial will be of 6 months duration. Intensive contact with participants will be maintained by case managers and psychiatrists throughout this time. Clinical, neuropsychological and neuroimaging measures will be taken at baseline and at various follow-up points (3, 6, 12, 24 months). Outcomes The primary outcome of interest is functional and symptomatic outcome (at 6, 12 and 24 months) in each treatment group. Specifically, it is of interest whether participants in the PIPT group achieve similar levels of functional and symptomatic improvement compared to the MIPT group at short- and long-term follow-up. Another outcome of interest is the proportion of the PIPT group who are not placed on antipsychotic medication during the 6-month period. These participants will have achieved satisfactory remission without antipsychotic medication. This sub-group will be compared on functioning and symptom scales to those randomised to the medication group and to those for whom antipsychotic medication was commenced due to worsening mental state and/or risk. Characteristics of this group will be analysed to determine the sub-group of FEP patients who may achieve remission from symptoms without antipsychotic medication. A PhD project has been added that will recruit a healthy comparison group to examine changes in physical health and neuropsychological functioning over time in the study age group.
Interventions
Intensive psychosocial intervention minus antipsychotic medication. Participants randomised to this intervention will be administered placebo tablets. The psychosocial intervention consists of four modules: intensive case management (engagement, problem solving, advocacy and support); close monitoring and crisis response; cognitive-behaviour therapy for symptoms; family support and education. The intensive psychosocial intervention will consist of twice-weekly contact with the treating team duri
Intensive psychosocial intervention minus antipsychotic medication. Participants randomised to this intervention will be administered placebo tablets. The psychosocial intervention consists of four modules: intensive case management (engagement, problem solving, advocacy and support); close monitoring and crisis response; cognitive-behaviour therapy for symptoms; family support and education. The intensive psychosocial intervention will consist of twice-weekly contact with the treating team during the first 2 months of the study, and weekly contact after the first 2 months. In total, the treatment will be provided for 6 months. Placebo medication will be titrated in 1mg increments at the discretion of the treating clinician over a four-week period, until a maximum maintenance dose of 6mg/day is reached, if required. Dose will be held at 2mg/day if adequate response is observed within 4 weeks. The medication will be packaged to allow flexible dosing.
Sponsors
Orygen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No
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
Outcome results
None listed