DepressionNAMHRNCT06115200
Norwegian Adult Mental Health Registry
An observational study of Depression and Schizophrenia, run by Helse Stavanger HF.
Trial summary
"The Norwegian Adult Mental Health Registry" (NAMHR) is a medical quality register collecting and systematizing data on patients and their treatment in specialist mental health care for adults in Norway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Schizophrenia, Bipolar Disorder
- How many people
- 150,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents in Norway aged 18 years or older and granted right to treatment in mental specialized in- and out-patient settings (approximately 150.000 participants)
Who may be able to join
- Residents in Norway aged 18 years or older assessed and granted right to treatment in specialized mental in- and out-patient settings
Who cannot join
- Persons who have reserved themselves against participation
- Persons already included in more specialized register for mental disorder and/or treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tore Tjora, PhD contact
About this study
"The Norwegian Adult Mental Health Registry" (NAMHR) is a medical quality register collecting and systematizing data on patients and their treatment in specialist mental health care for adults in Norway. The main purpose is to create a documentation basis for quality assurance, evaluation, and improvement of assessment and treatment for patients who are offered treatment for mental disorders in the specialist health service. The register uses automatic data capture from various existing data sources. New patients are automatically included, but given the opportunity for reservations from the register without affecting their services and treatment.
- Conditions
- Depression, Schizophrenia, Bipolar Disorder, Eating Disorders, Anxiety Disorders, Ptsd
- Keywords
- database, epidemiology, mental health register
- Medical subject headings
- Depression, Schizophrenia, Bipolar Disorder, Feeding and Eating Disorders, Anxiety Disorders, Stress Disorders, Post-Traumatic, Personality Disorders, Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcome Measures (PROMs)
Percentage of subjects that experienced change in PROMs
Measured: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Patient Reported Outcome Measures (PROMs)
Percentage of subjects that experienced change in PROMs
Measured: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Patient Reported Outcome Measures (PROMs)
Percentage of subjects that experienced change in PROMs
Measured: Six months after discharge
Drug name and dosage from electronic medication management solutions
Frequency of psychotropic generic drug name and dosage
Measured: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Drug name and dosage from electronic medication management solutions
Frequency of psychotropic generic drug name and dosage
Measured: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Drug name and dosage from electronic medication management solutions
Frequency of psychotropic generic drug name and dosage
Measured: Six months after discharge from any cause, assessed up to 12 months
Rate of overweight defined as BMI > 25 (body mass index)
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Measured: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Rate of overweight defined as BMI > 25 (body mass index)
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Measured: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Level of glycated haemoglobin (HbA1c)
Glycated hemoglobin is a form of hemoglobin chemically linked to sugar.
Measured: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Level of glycated haemoglobin (HbA1c)
Glycated hemoglobin is a form of hemoglobin chemically linked to sugar.
Measured: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Level of blood pressure, both systolic and diastolic levels
Blood pressure varies between systolic and diastolic pressures after each heartbeat. Systolic pressure is peak (maximum) pressure in the arteries. Diastolic pressure is the lowest (minimum) pressure in the arteries.
Measured: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Level of blood pressure, both systolic and diastolic levels
Blood pressure varies between systolic and diastolic pressures after each heartbeat. Systolic pressure is peak (maximum) pressure in the arteries. Diastolic pressure is the lowest (minimum) pressure in the arteries.
Measured: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Bloodlevels of total cholesterol, LDL, HDL and Triglycerides
A lipid profile (lipid panel) is a set blood tests used to find abnormalities in blood lipids. The present panel will include: total cholesterol, LDL, HDL and Triglycerides.
Measured: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Bloodlevels of total cholesterol, LDL, HDL and Triglycerides
A lipid profile (lipid panel) is a set blood tests used to find abnormalities in blood lipids. The present panel will include: total cholesterol, LDL, HDL and Triglycerides.
Measured: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Frequency of ICD-10 or ICD-11 diagnosis F00-F99
International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) or ISD-11: Chapter V: Mental and behavioural disorders (F00-F99)
Measured: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Frequency of ICD-10 or ICD-11 diagnosis F00-F99
International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) or ISD-11: Chapter V: Mental and behavioural disorders (F00-F99)Revision (ICD-10) WHO: Chapter V: Mental and behavioural disorders (F00-F99)
Measured: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 150,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Inge Joa, PhD, Principal investigator, Stavanger University hospital, Stavanger, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115200
- Sponsor's protocol ID
- NAMHR001
- Acronym
- NAMHR
- Status last verified
- May 2023
- First submitted
- 3 Jul 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tjora T, Jensen K, Dieset I, Fjukstad KK, Holman PA, Tesli M, Joa I. The Norwegian Adult Mental Health Registry for Quality Control in Specialized Mental Health Services: Protocol for a Nationwide Naturalistic Study. JMIR Res Protoc. 2026 Jan 23;15:e82696. doi: 10.2196/82696.
PubMed 41576321