Does Antipsychotic Dose Reduction in combination with Evidence-Based Intensive Recovery Treatment (EBIRT) Lead to Better Functional Recovery in First Episode Psychosis: A Randomised Controlled Trial

Not Applicable

• Conditions: First Episode Psychosis; Mental Health - Psychosis and personality disorders; Mental Health - Schizophrenia; Public Health - Health service research

• Registration Number: ACTRN12617000870358
• Lead Sponsor: Orygen, the National Centre of Excellence in Youth Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-15
• Study Completion: 2022-06-30
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

A participant will be considered eligible for inclusion in this study if all of the following criteria apply:

1.Current client of EPPIC
2.A confirmed diagnosis of first episode of a DSM-5 psychotic disorder or mood disorder with psychotic features as determined by the Structured Clinical Interview for DSM-5 Axis I Disorders, patient version (SCID-RV);
3.Aged 15-25 years (inclusive).
4. greater than or equal to 3 months of remission on positive symptoms of psychosis in the first year of antipsychotic treatment at EPPIC (a score of greater than or equal to 3 (mild) on the hallucinations, unusual thought disorder, conceptual disorganisation, and suspiciousness subscale items of the Brief Psychiatric Rating Scale (BPRS) for the past two weeks and a score greater than or equal to 3 on the hallucinations, unusual thought content, conceptual disorganisation, and suspiciousness subscales of the BRPS for the past 3 months based on a systematic clinical file review and collateral information collected from the participant’s treating team in EPPIC as needed).
5.Low suicidality defined as a score of 4 or below on the BPRS sustained for the past 1-month period from baseline.
6.The young person is willing for their carer to be informed about the study and will have at least weekly contact with their carer.
7. Ability to provide written informed consent.
•Where participants are under 18 years of age, consent will also be obtained from the participant’s parent or legal guardian. The parent or legal guardian and participant will both be required to sign a consent form.

Healthy controls will be aged 15-25 years (inclusive), who are able to attend appointments in Parkville, and have no self-reported history of mental illness, antipsychotic medication treatment, or neurological disorder.

Exclusion Criteria

FEP Exclusion Criteria
Participants who meet any of the following criteria will not be eligible for participation in this study:
1.A documented history of an intellectual disability or IQ <70
2.Inability to converse in or read English
3.Women who are currently pregnant or breastfeeding
4.Neurological disorder

Health Controls Exclusion Criteria:
Healthy controls will have no self-reported history of mental illness (including no history of a psychotic disorder), anti psychotic medication treatment or neurological disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Social and Occupational functioning assessed using the Social and Occupational Functioning Scale (SOFAS). [ 24 months ]