Psychosis; Schizophrenia-Like Clinical Trial
Official title:
Non-Pharmacological Treatment of Psychosis
| NCT number | NCT04051775 |
| Other study ID # | 2018/938 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 1, 2018 |
| Est. completion date | June 30, 2023 |
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | June 30, 2023 |
| Est. primary completion date | June 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Haukeland Univsersity Hospital | Bergen |
| Lead Sponsor | Collaborator |
|---|---|
| Haukeland University Hospital |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serious adverse events | To investigate the prevalence of any Serious Adverse Events (SAE) in the NorPharm group compared to the control group | One year | |
| Secondary | Time to remission | To investigate the time to remission (absence of positive psychotic symptoms as determined by the Positive And Negative Syndrome Scale) | One year | |
| Secondary | Time to recovery | To investigate the time to recovery (absence of positive psychotic symptoms plus normalized functioning) | One year | |
| Secondary | Time to relapse | To investigate the time to relapse (presence of positive psychotic symptoms) | One year | |
| Secondary | Insight | To investigate the change of insight as determined by Beck Cognitive Insight Scale (BCIS) | One year | |
| Secondary | Insight | To investigate the change of insight as determined by Medication Adherence Report Scale | One year | |
| Secondary | Insight | To investigate the change of insight as determined by Birchwood Insight Scale | One year |