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DepressionNCT07078227

Long-term Follow-up of Depressive Disorders in Psychiatric Care

An observational study of Depression and Psychiatric Diagnosis, run by Region Skane at 2 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The project investigates long-term prognosis and predictors of treatment outcomes for difficult-to-treat depression in patients in secondary psychiatric care. The current patient cohort was collected in 2012-2021 in the study "Pharmacogenetics in patients with depression with specific focus on difficult-to-treat… Read more about this study

Who is it for?
Ages 18 years and older
How many people
415 participants
Where
2 sitesSweden
Study dates
1 Jun 2025to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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: 415 patients from the study "Pharmacogenetics in depressive patients with specific focus on difficult-to-treat depression, suicide attempt and CYP2D6". The study population has been well described in earlier publications.

Who may be able to join

  • Participation in the study "Pharmacogenetics in depressive patients with specific focus on difficult-to-treat depression, suicide attempt and CYP2D6"

Who cannot join

  • Not wanting to participate in the follow-up study

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marie Asp, MD, PhD contact

+46702731013

marie.asp@skane.se

Sweden2 sites, 1 recruiting
  • Psychiatry Reserach Unit

    Lund, 221 85

    Active, not recruiting
  • Research Unit, Office of Psychiatricy, habilitation and technical aid

    Lund, 221 85

    Marie Asp, PhD, +46702731013, marie.asp@med.lu.se

    Recruiting

Other trials in Sweden

About this study

Official title: 5 Years Follow-up of the Study: "Pharmacogenetics in Depressed Patients With Specific Focus on Difficult-to-treat Depresssion, Suicide Attempt and CYP2D6"

The project investigates long-term prognosis and predictors of treatment outcomes for difficult-to-treat depression in patients in secondary psychiatric care. The current patient cohort was collected in 2012-2021 in the study "Pharmacogenetics in patients with depression with specific focus on difficult-to-treat depression, suicide attempt and CYP2D6". The cohort consists of 415 patients, examined carefully regarding diagnostic assessment and earlier treatment. All participants were also genotyped for the drug metabolizing enzymes CYP2D6 and CYP2C19. Blood samples were stored in biobank for other analyses linked to prognostic markers.

The patient cohort will now be followed up with a review of medical records and extraction of register data for a period of 5 years after their participation in the original study. The purpose of the study is to improve treatment and increase knowledge about long-term prognosis in difficult-to-treat depression. This is done by examining symptom profiles, monitoring clinical course and suicidality, and examining prognostic markers.

Read the detailed description

BACKGROUND

It is very important to understand the course of depressive disorders over time in long time follow-up studies. A cross-sectional observational study "Pharmacogenetics in depressed patients with a special focus on difficult-to-treat depression, suicide attempts and CYP2D6" (n=415) was performed in Sweden 2012-2021. Participants were genotyped for enzymes within the Cytochrome P450 system - CYP2D6 and CYP2C19. Participants were also examined very carefully with regard to diagnostic assessment with structured and semi-structured diagnostic instruments: MINI neuropsychiatric interview (MINI) and structured clinical interview for DSM-IV-TR axis II (SCID-II). Comprehensive psychipatological rating scale (CPRS) was used as well as Montgomery Asberg depression rating scale (MADRS), the UKU side effect rating scale (UKU-SERS) , Suicidal assessment scale (SUAS) and Alcohol Use Disorder Identification Test (AUDIT) and Drug Use Disorder Identification Test (DUDIT) as well as thorough survey of the clinical course of psychiatric symptoms. Blood samples were collected and stored in biobank. The participants with CYP2D6UM and CYP2D6PM were offered pharmacological counseling to optimize treatment during 8 weeks.

The same patients will now be followed over a five-year period after participation in the original study, in order to better understand the long-term prognosis of depression and the factors that can predict the course of the disorder over time.

OBJECTIVE

The overall goal is to improve treatment and increase knowledge about difficult-to-treat depression, as well as to investigate how biological and clinical variables can predict treatment outcomes and long-term outcomes.

PURPOSE

To investigate diagnoses and diagnostic assessment, long-term prognosis, symptom profiles and prognostic markers as well as suicidality and effect of pharmacologic counseling in depression. The cohort contains patients with both unipolar and bipolar depression.

METHOD

Research subjects who have participated in the original study during the period 2012-2021 (n=415) will participate in the follow up study unless they oppose to do so. The original study has already been presented in earlier publications with regard to diagnostics treatment linked to clinical parameters and suicide attempts, inflammation, vitamin D, mitochondrial DNA, CYP2D6, and coping.

Data collection for this follow-up study is based on an approved opt-out procedure from the Swedish Ethical Review Authority (dnr: 2024-04820-02 and 2025-03351-02)). Participants are given the opportunity to decline participation in the study by responding via letter or questionnaire responses digitally. If participants do not respond within 4 weeks, they are automatically included in the study.

Data will be collected through medical records review and extraction of register data. The data collection will be for a period of 5 years from participation in the original study.

The following information is collected from medical records: Information on suicide attempts, inpatient treatment, emergency room visits, outpatient visits, treatment received, ICD diagnoses, descriptions of personality functioning, markers for clinical improvement, if CYP2D6UM and CYP2D6PM have been subject to specific considerations in choice of drug treatment.

Registers will be used when needed for data collection, from the Longitudinal Integration Database for Health Insurance and Labour Market Studies, the Pharmaceutical Register, the Patient Register, the Cause of Death Register.

Being tested
No intervention is used.
Medical subject headings
Depression, Mental Disorders, Personality Disorders, Suicide, Attempted, Anhedonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention is used.Other

    No intervention is used.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Suicide attempt and suicide

    The frequency of suicide attempts and completed suicides in the patient sample over the follow-up period of 5 years

    Measured: 5 years follow-up after baseline visit.

  2. Clinical course of depression

    Course of depressive disorder during the follow-up period measured by information from medical records, where the reserach psychiatrist makes an assessment dichotomized as improved or not improved based on the available information.

    Measured: 5 years follow-up after baseline visit

  3. Comparison of diagnostic assessment for personality disorders

    Comparison of frequency of DSM-IV-TR personality disorders and ICD-11 personality disorders in the sample. ICD-11 personality disorders will also be divided into degree of difficulty as well as which specifiers of prominent traits are present in the population of difficult-to-treat depression

    Measured: Baseline data and 5 years follow-up from inclusion.

  4. Course and diagnostic characteristics of bipolar disorder

    Historical order of diagnoses before bipolar diagnosis and the development of diagnostic assessment during follow-up as well as personality assessment according to DSM-IV and ICD-11.

    Measured: Baseline data and 5 years follow-up after inclusion.

  5. Results from pharmacological counseling for CYP2D6UM och CYP2D6PM

    Change in score for Montgomery Åsberg Depression Rating Scale from week 0 to 8 (total of 9 weeks) during pharmacological counseling.

    Data from medical records for 5 years follow-up will be used to investigate adherence to recommendations during pharmacologic counseling and in a long term perspective.

    Measured: Nine weeks of pharmacological counseling after baseline and 5 years follow-up from baseline visit

  6. Prediction of long-term prognosis of depressive symptom profiles

    Data on clinical outcome over 5 years follow-up for depressive symptom profiles with specific focus on anhedonic symtom profile derived from the Comprehensive Psychopatholocial Rating Scale (CPRS) and depression characteristics.

    Measured: 5 years follow-up from baseline visit

  7. Course of disease related to dopamine D3 receptor and other biomarkers

    The relationship between the course of depressive disorder and biomarkers including dopamine D3 receptor, other biomarkers of dopaminergic function, inflammation and other types of biomarkers

    Measured: 5 years follow-up from baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start1 Jun 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
415 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07078227
Sponsor's protocol ID
2024-04820-02
Status last verified
Apr 2026
First submitted
13 Mar 2025
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Asp M, Lindqvist D, Fernstrom J, Ambrus L, Tuninger E, Reis M, Westrin A. Recognition of personality disorder and anxiety disorder comorbidity in patients treated for depression in secondary psychiatric care. PLoS One. 2020 Jan 2;15(1):e0227364. doi: 10.1371/journal.pone.0227364. eCollection 2020.

    PubMed 31895938
  • Asp M, Ambrus L, Reis M, Manninen S, Fernstrom J, Lindqvist D, Westrin A. Differences in antipsychotic treatment between depressive patients with and without a suicide attempt. Compr Psychiatry. 2021 Aug;109:152264. doi: 10.1016/j.comppsych.2021.152264. Epub 2021 Jul 8.

    PubMed 34271258
  • Soderberg Veiback G, Malmgren L, Asp M, Ventorp F, Suneson K, Grudet C, Westrin A, Lindqvist D. Inflammatory depression is associated with selective glomerular hypofiltration. J Affect Disord. 2024 Jul 1;356:80-87. doi: 10.1016/j.jad.2024.04.007. Epub 2024 Apr 2.

    PubMed 38574872
  • Suneson K, Grudet C, Ventorp F, Malm J, Asp M, Westrin A, Lindqvist D. An inflamed subtype of difficult-to-treat depression. Prog Neuropsychopharmacol Biol Psychiatry. 2023 Jul 13;125:110763. doi: 10.1016/j.pnpbp.2023.110763. Epub 2023 Apr 8.

    PubMed 37037323
  • Grudet C, Wolkowitz OM, Mellon SH, Malm J, Reus VI, Brundin L, Nier BM, Dhabhar FS, Hough CM, Westrin A, Lindqvist D. Vitamin D and inflammation in major depressive disorder. J Affect Disord. 2020 Apr 15;267:33-41. doi: 10.1016/j.jad.2020.01.168. Epub 2020 Jan 29.

    PubMed 32063570
  • Fernstrom J, Ohlsson L, Asp M, Lavant E, Holck A, Grudet C, Westrin A, Lindqvist D. Plasma circulating cell-free mitochondrial DNA in depressive disorders. PLoS One. 2021 Nov 4;16(11):e0259591. doi: 10.1371/journal.pone.0259591. eCollection 2021.

    PubMed 34735532
  • Holck A, Asp M, Green H, Westrin A, Reis M. CYP2D6 Genotyping and Inhibition as Predictors of Adverse Drug Reactions in Depressive Disorders. J Clin Psychiatry. 2024 Jan 17;85(1):23m14937. doi: 10.4088/JCP.23m14937.

    PubMed 38236047
  • Ambrus L, Sunnqvist C, Asp M, Westling S, Westrin A. Coping and suicide risk in high risk psychiatric patients. J Ment Health. 2020 Feb;29(1):27-32. doi: 10.1080/09638237.2017.1417547. Epub 2017 Dec 20.

    PubMed 29260914

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Psychiatric Diagnosis, run by Region Skane at 2 sites in Sweden.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marie Asp, MD, PhD (+46702731013, marie.asp@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suicide attempt and suicide (time frame: 5 years follow-up after baseline visit.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07078227, which also lists 8 linked publications.

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 30 Apr 2026.

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