Non-Pharmacological Treatment of Psychosis
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedAugust 3, 2022
July 1, 2022
4.6 years
May 16, 2019
August 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Time to remission
One year
Time to recovery
One year
Time to relapse
One year
Insight
One year
Insight
One year
- +1 more secondary outcomes
Eligibility Criteria
Eligible patients are those seeking NonPharm treatment who has a diagnosis of schizophrenia or related disorder (corresponding to chapter F2 in the ICD-10). Eligible patients will be included from the Division of Psychiatry, Haukeland University Hospital and collaborating District Psychiatric Centers in the same catchment area. The catchment population is 400.000. Both in- and out-patients are eligible for the study.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haukeland Univsersity Hospital
Bergen, 5021, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2019
First Posted
August 9, 2019
Study Start
December 1, 2018
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
August 3, 2022
Record last verified: 2022-07