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Trial registered on ANZCTR
Registration number
ACTRN12607000608460
Ethics application status
Approved
Date submitted
26/11/2007
Date registered
28/11/2007
Date last updated
2/12/2021
Date data sharing statement initially provided
2/12/2021
Date results information initially provided
2/12/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
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
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Scientific title
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 to evaluate the impact on functioning and symptomatology. The STAGES Study: Staged Treatment and Acceptability Guidelines in Early Psychosis
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Secondary ID [1]
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Nil
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Universal Trial Number (UTN)
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Trial acronym
STAGES study of first episode psychosis
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
First episode psychosis
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Condition category
Condition code
Mental Health
2686
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0
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
2312
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Treatment: Other
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Comparator / control treatment
Intensive psychosocial intervention plus antipsychotic medication. This 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. The antipsychotic medication will be risperidone. Trial 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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Social and occupational functioning, as rated on the Social and Occupational Functioning Assessment Scale (SOFAS).
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Assessment method [1]
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Timepoint [1]
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6, 12, 24 months
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Secondary outcome [1]
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Psychiatric symptomatology, including positive psychotic symptoms, negative psychotic symptoms, and mood and anxiety symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS).
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Assessment method [1]
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Timepoint [1]
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6, 12, 24 months
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Eligibility
Key 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.
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Minimum age
15
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A psychiatrist, case manager and research assistant will determine if the subject is eligible for inclusion in the trial. Allocation will be concealed by contacting the holder of the allocation schedule who is "off-site".
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified randomisation design will be used to allocate subjects to either one of the treatment groups. It has been established that duration of untreated psychosis and gender are associated with functional outcome, the key outcome measure in this study. Hence, we will be using characteristics as stratifying factors in the randomisation, since any chance imbalances on these prognostic variables may bias the analysis. Duration of untreated psychosis will be included as a three-level factor; < 1 month; 1 month to < 3 months, 3 months to 6 months. Along with gender, this will result in six separate randomisation lists from which subjects will be drawn. Subjects will be allocated to either one of the treatment groups using randomly permuted blocks within each stratum, to ensure that subject allocation to the treatment groups is approximately equal.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
27/11/2007
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Actual
7/04/2008
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Date of last participant enrolment
Anticipated
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Actual
31/12/2018
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Date of last data collection
Anticipated
4/11/2018
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Actual
31/07/2019
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Sample size
Target
95
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Accrual to date
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Final
118
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
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3052
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC project grant
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Address [1]
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National Health and Medical Research Council
GPO Box 1421 (Level 1, 16 Marcus Clarke Street)
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Other
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Name
Orygen
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Address
35 Poplar Road (Locked Bag 10)
Parkville
Victoria 3052
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Melbourne Health, Office for Research
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Ethics committee address [1]
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Royal Melbourne Hospital
Parkville
Victoria 3052
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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17/07/2007
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Ethics approval number [1]
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2007.016
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Summary
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.
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Trial website
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Trial related presentations / publications
Francey, S.M., O’Donoghue, B., Nelson, B., Graham, J., Baldwin, L., Fornito, A., Allott, K., Alvarez-Jimenez, M., Harrigan, S., Yuen, H.K. & McGorry, P.D. (2018, February). Antipsychotic medication in first-episode psychosis: An RCT to assess the risk-benefit ratio. Paper presented at the World Psychiatric Association Thematic Congress, Melbourne, Australia.
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Public notes
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Contacts
Principal investigator
Name
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Prof Patrick McGorry
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Address
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Orygen, The National Centre of Excellence in Youth Mental Health
Locked Bag 10 (35 Poplar Road)
Parkville Victoria 3052
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Country
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Australia
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Phone
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+61 3 9966 9100
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Shona Francey
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Address
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Orygen, Parkville, Victoria, 3052
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Country
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Australia
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Phone
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+61 3 9966 9226
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Shona Francey
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Address
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35 Poplar Road
Parkville
Victoria 3052
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Country
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Australia
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Phone
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+61 3 9966 9226
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
This study commenced in 2007, when data sharing was less common, and participants were not asked to give consent to data sharing. Thus it is not considered ethical to share individual participant data when informed consent has not been obtained.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
14318
Informed consent form
[email protected]
14319
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Francey, S.M., O’Donoghue, B., Nelson, B., Graham,...
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82439-(Uploaded-08-03-2021-18-30-47)-Journal results publication.pdf
Study results article
Yes
Whitson, S., O'Donoghue, B., Hester, R., Baldwin, ...
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Study results article
Yes
Sidhant, C., Alex Fornito, A., Francey, S.M., O’Do...
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Basic results
No
82439-(Uploaded-13-04-2021-16-21-08)-Basic results summary.docx
Plain language summary
No
This study examined whether antipsychotic medicati...
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Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Isolating the impact of antipsychotic medication on metabolic health: Secondary analysis of a randomized controlled trial of antipsychotic medication versus placebo in antipsychotic medication naive first-episode psychosis (the STAGES study).
2023
https://dx.doi.org/10.1111/eip.13353
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Gradients of striatal function in antipsychotic-free first-episode psychosis and schizotypy.
2023
https://dx.doi.org/10.1038/s41398-023-02417-2
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Functional Connectivity in Antipsychotic-Treated and Antipsychotic-Naive Patients with First-Episode Psychosis and Low Risk of Self-harm or Aggression: A Secondary Analysis of a Randomized Clinical Trial.
2021
https://dx.doi.org/10.1001/jamapsychiatry.2021.1422
Embase
Psychological interventions for psychosis in adolescents.
2020
https://dx.doi.org/10.1002/14651858.CD009533.pub2
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Should people with psychosis be supported in choosing cognitive therapy as an alternative to antipsychotic medication: A commentary on current evidence.
2019
https://dx.doi.org/10.1016/j.schres.2018.03.010
Embase
Staged treatment and acceptability guidelines in early psychosis study (STAGES): A randomized placebo controlled trial of intensive psychosocial treatment plus or minus antipsychotic medication for first-episode psychosis with low-risk of self-harm or aggression. Study protocol and baseline characteristics of participants.
2019
https://dx.doi.org/10.1111/eip.12716
N.B. These documents automatically identified may not have been verified by the study sponsor.
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