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.
Study Type
OBSERVATIONAL
Enrollment
50
Haukeland Univsersity Hospital
Bergen, Norway
RECRUITINGSerious adverse events
To investigate the prevalence of any Serious Adverse Events (SAE) in the NorPharm group compared to the control group
Time frame: One year
Time to remission
To investigate the time to remission (absence of positive psychotic symptoms as determined by the Positive And Negative Syndrome Scale)
Time frame: One year
Time to recovery
To investigate the time to recovery (absence of positive psychotic symptoms plus normalized functioning)
Time frame: One year
Time to relapse
To investigate the time to relapse (presence of positive psychotic symptoms)
Time frame: One year
Insight
To investigate the change of insight as determined by Beck Cognitive Insight Scale (BCIS)
Time frame: One year
Insight
To investigate the change of insight as determined by Medication Adherence Report Scale
Time frame: One year
Insight
To investigate the change of insight as determined by Birchwood Insight Scale
Time frame: One year
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