Non-Pharmacological Treatment of Psychosis

• Conditions: Psychosis; Schizophrenia-Like

• Registration Number: NCT04051775
• Lead Sponsor: Haukeland University Hospital

Brief Summary

The objectives of the project are to investigate feasibility, safety, and health-related outcomes in patients with psychosis who choose not to use antipsychotic drugs (APs). The instruction from the Ministry of Health and Care Services to establish "Medication Free" (non-pharmacological (NonPharm)) treatment services, which has received substantial critique for being given without support in scientific evidence, provides a window of opportunity for research in an under-investigated field. The study will prospectively follow a cohort over 1 year who seeks NonPharm treatment, with repeated measurements of symptoms, functional outcomes, quality of life, adverse events, as well as biological parameters including genetics and brain imaging, and environmental factors, and compare the findings to a control group of users of antipsychotic drugs, matched for age, gender and diagnosis. Current unanswered questions in the treatment of psychosis include which patients can successfully and safely discontinue antipsychotic medication; and what are the long-term symptomatic, biological and functional outcomes after use or non-use of APs, respectively. Taken together there is a fundamental lack of high-quality evidence to guide the treatment options in people who cannot or do not want to use APs in psychosis. This is also a major challenge in the study, as a more rigorous design that could directly compare different treatment options is not feasible, because no alternatives to APs have proven to be sufficiently effective and safe in controlled trials. The study is accordingly expected to provide new exploratory information that could be the basis of intervention studies which in its turn could provide important information for consumers and the mental health services regarding treatment options in psychosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Fulfillment of diagnostic criteria for schizophrenia or related disorder (corresponding to chapter F2 in the ICD-10)
• The clinician responsible for the treatment must consider nonpharmacological treatment to be professionally justifiable in the patient in question
• Patient being able/ capable of providing informed consent
• Patient receiving active treatment including different psychosocial treatments
• Patient having a treatment plan and a crisis resolution plan.

Exclusion Criteria Not fullfilling inclusion criteria

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious adverse events	One year	To investigate the prevalence of any Serious Adverse Events (SAE) in the NorPharm group compared to the control group

Secondary Outcome Measures

Name	Time	Method
Time to relapse	One year	To investigate the time to relapse (presence of positive psychotic symptoms)
Time to recovery	One year	To investigate the time to recovery (absence of positive psychotic symptoms plus normalized functioning)
Insight	One year	To investigate the change of insight as determined by Birchwood Insight Scale
Time to remission	One year	To investigate the time to remission (absence of positive psychotic symptoms as determined by the Positive And Negative Syndrome Scale)

Trial Locations

Locations (1)

Haukeland Univsersity Hospital; 🇳🇴 Bergen, Norway