Norwegian Adult Mental Health Registry

Depression Clinical Trial

— NAMHR  

Official title:

Norwegian Adult Mental Health Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06115200
• Other study ID #: NAMHR001
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2023
• Source: Helse Stavanger HF
• Contact: Inge Joa, PhD
• Phone: +4791392373
• Email: inge.joa[@]sus.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Residents in Norway aged 18 years or older assessed and granted right to treatment in specialized mental in- and out-patient settings

Exclusion Criteria:

• Persons who have reserved themselves against participation

• Persons already included in more specialized register for mental disorder and/or treatment

Related Conditions & MeSH terms

• Adhd
• Anxiety Disorders
• Bipolar Disorder
• Depression
• Eating Disorders
• Feeding and Eating Disorders
• Personality Disorders
• Ptsd
• Schizophrenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Reported Outcome Measures (PROMs)	Percentage of subjects that experienced change in PROMs	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
Primary	Patient Reported Outcome Measures (PROMs)	Percentage of subjects that experienced change in PROMs	Discharge defined as: date of discharge from any cause, assessed up to 60 months
Primary	Patient Reported Outcome Measures (PROMs)	Percentage of subjects that experienced change in PROMs	Six months after discharge
Primary	Drug name and dosage from electronic medication management solutions	Frequency of psychotropic generic drug name and dosage	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
Primary	Drug name and dosage from electronic medication management solutions	Frequency of psychotropic generic drug name and dosage	Discharge defined as: date of discharge from any cause, assessed up to 60 months
Primary	Drug name and dosage from electronic medication management solutions	Frequency of psychotropic generic drug name and dosage	Six months after discharge from any cause, assessed up to 12 months
Primary	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.	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
Primary	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.	Discharge defined as: date of discharge from any cause, assessed up to 60 months
Primary	Level of glycated haemoglobin (HbA1c)	Glycated hemoglobin is a form of hemoglobin chemically linked to sugar.	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
Primary	Level of glycated haemoglobin (HbA1c)	Glycated hemoglobin is a form of hemoglobin chemically linked to sugar.	Discharge defined as: date of discharge from any cause, assessed up to 60 months
Primary	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.	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
Primary	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.	Discharge defined as: date of discharge from any cause, assessed up to 60 months
Primary	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.	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
Primary	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.	Discharge defined as: date of discharge from any cause, assessed up to 60 months
Primary	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)	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
Primary	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)	Discharge defined as: date of discharge from any cause, assessed up to 60 months