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

NCT07078227 | Recruiting

• 1 other identifier: 2024-04820-02
• Study Type: observational
• Target: 415
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Depression; Psychiatric Diagnosis; Personality Disorders; Suicide, Attempted; CYP2D6 Polymorphism; Anhedonia

Outcome Measures

Primary Outcomes (7)

• Suicide attempt and suicide

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

  5 years follow-up after baseline visit.

• 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.

  5 years follow-up after baseline visit

• 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

  Baseline data and 5 years follow-up from inclusion.

• 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.

  Baseline data and 5 years follow-up after inclusion.

• 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.

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

• 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.

  5 years follow-up from baseline visit

• 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

  5 years follow-up from baseline visit

Interventions

No intervention is used. OTHER

No intervention is used.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• Not wanting to participate in the follow-up study

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (2)

Psychiatry Reserach Unit

Lund, 221 85, Sweden

ACTIVE NOT RECRUITING

Research Unit, Office of Psychiatricy, habilitation and technical aid

Lund, 221 85, Sweden

RECRUITING

Related Publications (8)

• 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.

  PMID: 31895938 BACKGROUND

• 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.

  PMID: 34271258 BACKGROUND

• 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.

  PMID: 38574872 BACKGROUND

• 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.

  PMID: 37037323 BACKGROUND

• 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.

  PMID: 32063570 BACKGROUND

• 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.

  PMID: 34735532 BACKGROUND

• 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.

  PMID: 38236047 BACKGROUND

• 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.

  PMID: 29260914 BACKGROUND

MeSH Terms

Conditions

Depression; Mental Disorders; Personality Disorders; Suicide, Attempted; Anhedonia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marie Asp, MD, PhD

CONTACT

+46702731013; marie.asp@skane.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: July 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)