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Search / Trial NCT05833087

Schema Therapy for Patients With Chronic Treatment Resistant Depression

Launched by REGION OF SOUTHERN DENMARK · Apr 15, 2023

Trial Information

Current as of September 02, 2025

Recruiting

Keywords

Treatment Resistant Depression Schema Therapy Psychotherapy Difficult To Treat Depression Chronic Depression Clinical Trial Randomized Controlled Trial

ClinConnect Summary

This clinical trial is studying a type of therapy called schema therapy to see if it can help people with chronic treatment-resistant depression. This is a form of depression that is hard to treat with regular medications or therapies. The researchers want to find out if schema therapy is more effective than standard psychotherapy options currently offered. Participants will be divided into two groups: one will receive 30 sessions of schema therapy, while the other group will get 6-16 sessions of different types of psychotherapy. Both groups will also have access to regular mental health care.

To be eligible for this study, participants should be adults who have been diagnosed with chronic or treatment-resistant depression for at least two years or who have not improved after trying different antidepressants. They should also have moderate to severe depression scores. However, individuals with current substance abuse, bipolar disorder, or who are at high risk of suicide cannot participate. This trial aims to expand treatment options for those struggling with difficult-to-treat depression, potentially leading to more effective therapies in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Participants have at the time of inclusion been referred to treatment for depression as a primary diagnosis in a psychiatric clinic
  • * Participants should meet the diagnosis of chronic or treatment-resistant depression as follows:
  • 1. Clinical major depression as measured by the M.I.N.I. diagnostic interview: duration minimum two years OR persistent after = 2 trials of antidepressants from different classes, in an adequate dosage and time period (= 4 weeks) OR moderate treatment resistance as measured on the MSM-scale, score \> 6
  • 2. Minimum a score of 9 points on the Hamilton Rating Scale for Depression 6 (HAMD-6), corresponding to moderate to severe depression
  • Exclusion Criteria:
  • Alcohol or substance abuse
  • Bipolar or psychotic disorder
  • Acute suicidal risk
  • Mental disability (estimated IQ \< 70)
  • Non-Danish speaker
  • Known to be pregnant at time of inclusion
  • Psychiatric comorbidity is not an exclusion criteria, until the comorbid disorder is understood to be the primary psychiatric problem and as such the patient would be treated in a different care package, e.g., for Post-Traumatic Stress Disorder

About Region Of Southern Denmark

The Region of Southern Denmark is a leading clinical trial sponsor dedicated to advancing medical research and improving patient care through innovative studies. Comprising a network of hospitals and healthcare facilities, the region fosters collaboration among healthcare professionals, researchers, and industry partners to facilitate the development of new therapies and treatments. By prioritizing ethical standards and patient safety, the Region of Southern Denmark aims to contribute significantly to the global medical research landscape while enhancing health outcomes for its diverse population.

Locations

Ballerup, , Denmark

Copenhagen, , Denmark

Frederiksberg, , Denmark

Odense, , Denmark

Frederiksberg, , Denmark

Patients applied

0 patients applied

Trial Officials

Stine B. Moeller, PhD

Principal Investigator

Region of Southern Denmark Psychiatry; University of Southern Denmark

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported