Psychosis; Schizophrenia-LikeNCT04051775
Non-Pharmacological Treatment of Psychosis
An observational study of Psychosis; Schizophrenia-Like, run by Haukeland University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychosis; Schizophrenia-Like
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 1 Dec 2018to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland Univsersity Hospital
Bergen, 5021
Erik Johnsen, PhD, 0047 55958400, erik.johnsen@helse-bergen.no
About this study
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.
- Conditions
- Psychosis; Schizophrenia-Like
- Medical subject headings
- Psychotic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events
To investigate the prevalence of any Serious Adverse Events (SAE) in the NorPharm group compared to the control group
Measured: One year
Secondary outcomes (6)
Time to remission
To investigate the time to remission (absence of positive psychotic symptoms as determined by the Positive And Negative Syndrome Scale)
Measured: One year
Time to recovery
To investigate the time to recovery (absence of positive psychotic symptoms plus normalized functioning)
Measured: One year
Time to relapse
To investigate the time to relapse (presence of positive psychotic symptoms)
Measured: One year
Insight
To investigate the change of insight as determined by Beck Cognitive Insight Scale (BCIS)
Measured: One year
Insight
To investigate the change of insight as determined by Medication Adherence Report Scale
Measured: One year
Insight
To investigate the change of insight as determined by Birchwood Insight Scale
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Dec 2018
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosis; Schizophrenia-LikeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051775
- Sponsor's protocol ID
- 2018/938
- Status last verified
- Jul 2022
- First submitted
- 16 May 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Pharmacological Treatment of Psychosis
- ClinicalTrials.gov ID
- NCT04051775
- Acronym / sponsor ID
- 2018/938
- Conditions
- Psychosis; Schizophrenia-Like
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serious adverse events
Time frame: One year
To investigate the prevalence of any Serious Adverse Events (SAE) in the NorPharm group compared to the control group
6 secondary outcomes
Time to remission
Time frame: One year
Time to recovery
Time frame: One year
Time to relapse
Time frame: One year
Insight
Time frame: One year
Insight
Time frame: One year
Insight
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis; Schizophrenia-Like, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik Johnsen, PhD (0047 55958400, erik.johnsen@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.