Precision Medicine in the Depression Treatment

NCT05616559 | Recruiting

• 1 other identifier: H-20083013
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The BrainDrugs-D study uses multimodal neuroimaging combined with self-report measures, clinical and molecular markers to identify clinically relevant predictors that can identify subtypes of major depressive disorder (MDD) and, in a naturalistic setting, predict treatment response to standard antidepressive treatment. The cohorts are followed in nationwide health registries.

Conditions

Depressive Disorder, Major; Treatment Outcome; Cognitive Dysfunction; Cognitive Behavioral Therapy; Antidepressive Agents

Keywords

PET; MRI; fMRI; EEG; Prediction of treatment response; Early life stress; Selective Serotonin Reuptake Inhibitor; Psychometrics; MDD; Cold cognition; Social cognition; Anxiety

Outcome Measures

Primary Outcomes (2)

• Clinical remission

  Quick Inventory of Depressive Symptomatology (QIDS) score of ≤5

  Baseline to 6 months after treatment start

• Clinical improvement

  ≥50% reduction in QIDS score.

  Baseline to 6 months after treatment start

Secondary Outcomes (5)

• Changes in depression severity

  Baseline to 6, 12 and 18 months after treatment start

• Changes in symptomatology

  Baseline to 6, 12 and 18 months after treatment start

• Changes in depression and anxiety symptomatology

  Baseline to 6, 12 and 18 months after treatment start

• Change in wellbeing

  Baseline to 6, 12 and 18 months after treatment start

• Change in disability

  Baseline to 6, 12 and 18 months after treatment start

Other Outcomes (3)

• Medication side-effects

  Baseline to 6 months after treatment start

• Adverse and unwanted events in psychotherapy

  Baseline to 6 months after treatment start

• Psychosocial remission

  Baseline to 6, 12 and 18 months after treatment start

Study Arms (3)

Patient cohort (n=800)

All participants included will contribute with basic clinical, cognitive, psychometric, genetic and biochemical data.

Combination Product: Treatment Package for First-Episode Depression

Subcohort I (n=600)

Patients in Subcohort I undergo MRI and EEG in addition to expanded clinical, cognitive, psychometric, and biological data.

Combination Product: Treatment Package for First-Episode Depression

Subcohort II - drug naive PET subgroup (n=60)

A subgroup of Subcohort I, including only patients who at inclusion do not receive any pharmacological treatment for their depression, undergo in addition Positron Emission Tomography imaging with \[11C\]-UCB-J for measurement of cerebral synaptic density.

Combination Product: Treatment Package for First-Episode Depression

Interventions

Treatment Package for First-Episode Depression COMBINATION_PRODUCT

The outpatient 'treatment package' for first episode depression is a national uniform package designed by Mental Health Services in the Capital Region. The treatment package for first-episode depression is a program with manualized group CBT, psychoeducation of patients and relatives, and relapse prevention. Antidepressant medication and individual psychotherapy are available as needed.

Patient cohort (n=800); Subcohort I (n=600); Subcohort II - drug naive PET subgroup (n=60)

Eligibility Criteria

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

Study Population

The Capital Region of Denmark is the most urban area of Denmark and has a population of 1.6 million people. Patients in the Capital Region of Denmark are referred from their general practitioner or other treatment providers for treatment within the mental health services in the region. All six clinics in the region provide treatment packages for first-episode depression.

You may qualify if:

• Age between 18 and 65 years
• Fulfilment of International Classification of Diseases version 10 diagnostic criteria for a primary depressive episode (i.e., not secondary to known organic or other psychiatric disorder).
• Referral to a treatment package for single-episode depression.

You may not qualify if:

• Psychosis or psychotic symptoms
• History of severe head trauma
• Somatic disease associated with morphological brain changes (e.g., brain tumour)
• Insufficient Danish language skills to complete questionnaires and cognitive testing
• Severe somatic disease
• Contraindications for MRI (e.g., metal implants, claustrophobia or back problems)
• Severe somatic disease
• Contraindications for MRI
• Exposure to radioactivity \>10 mSv within the last year
• Pregnancy or breastfeeding
• Use of psychotropic drugs

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator
• Center for Integrated Molecular Brain Imaging, Copenhagen, Denmak: collaborator
• Lundbeck Foundation: collaborator

Study Sites (1)

Neurobiology Research Unit, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (4)

• Cipriani A, Furukawa TA, Salanti G, Chaimani A, Atkinson LZ, Ogawa Y, Leucht S, Ruhe HG, Turner EH, Higgins JPT, Egger M, Takeshima N, Hayasaka Y, Imai H, Shinohara K, Tajika A, Ioannidis JPA, Geddes JR. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018 Apr 7;391(10128):1357-1366. doi: 10.1016/S0140-6736(17)32802-7. Epub 2018 Feb 21.

  PMID: 29477251 BACKGROUND

• Trevino K, McClintock SM, McDonald Fischer N, Vora A, Husain MM. Defining treatment-resistant depression: a comprehensive review of the literature. Ann Clin Psychiatry. 2014 Aug;26(3):222-32.

  PMID: 25166485 BACKGROUND

• Kessler RC, van Loo HM, Wardenaar KJ, Bossarte RM, Brenner LA, Ebert DD, de Jonge P, Nierenberg AA, Rosellini AJ, Sampson NA, Schoevers RA, Wilcox MA, Zaslavsky AM. Using patient self-reports to study heterogeneity of treatment effects in major depressive disorder. Epidemiol Psychiatr Sci. 2017 Feb;26(1):22-36. doi: 10.1017/S2045796016000020. Epub 2016 Jan 26.

  PMID: 26810628 BACKGROUND

• Jensen KHR, Dam VH, Ganz M, Fisher PM, Ip CT, Sankar A, Marstrand-Joergensen MR, Ozenne B, Osler M, Penninx BWJH, Pinborg LH, Frokjaer VG, Knudsen GM, Jorgensen MB. Deep phenotyping towards precision psychiatry of first-episode depression - the Brain Drugs-Depression cohort. BMC Psychiatry. 2023 Mar 9;23(1):151. doi: 10.1186/s12888-023-04618-x.

  PMID: 36894940 DERIVED

Related Links

• Description of treatment package (in Danish)

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Depressive Disorder, Major; Cognitive Dysfunction; Stress, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Behavioral Symptoms; Behavior

Study Officials

• Martin B Jørgensen, DMSc

  Psychiatric Center Copenhagen

  PRINCIPAL INVESTIGATOR

• Gitte MK Knudsen, DMSc

  Neurobiology Research Unit, Rigshospitalet

  STUDY DIRECTOR

Central Study Contacts

Kristian HR Jensen, MD

CONTACT

+45 35456720; kristian.reveles.jensen@nru.dk

Martin B Jørgensen, DMSc

CONTACT

+45 38647082; Martin.Balslev.Joergensen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Professor

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 15, 2022
• Study Start: June 15, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon study completion
• Access Criteria: Researchers may apply for access to the data.

Locations

DK (1)